GLP-1 Orange Book Guide: How to Read the FDA's Official Record for Any GLP-1

Last verified: August 18, 2026 · Current FDA databases checked August 18, 2026 · Monthly-file cross-check through the July 2026 cumulative supplement · GLP-1 FDA Record Map, version 1.1

Affiliate disclosure: The RX Index earns commissions from some providers we link to elsewhere on this site. This page does not rank or recommend any provider, and no company paid to influence anything on it.

By The RX Index editorial team

This GLP-1 Orange Book guide shows you exactly where to check any GLP-1 medication in the FDA's own files — and what the record actually proves. Most stand-alone GLP-1 medicines live in the Orange Book. Trulicity, Adlyxin, Tanzeum, Xultophy, and Soliqua live in the Purple Book. Compounded semaglutide and tirzepatide are in neither one, because they are not FDA-approved.

Here's the short version, before you scroll.

The Orange Book has records for Ozempic injection, Ozempic tablets, Rybelsus, Wegovy injection, Wegovy tablets, Mounjaro, Zepbound, Victoza, Saxenda, Byetta, Bydureon BCise, and Foundayo. The Purple Book has Trulicity, Adlyxin, Tanzeum, Xultophy, and Soliqua. Compounded GLP-1 products have no FDA approval record in either book.

What changes the answer: the molecule's legal classification helps decide which book applies. A 2020 federal transition moved certain protein products from drug applications to biologics licenses. Fixed-ratio products can also land in the Purple Book because they include a biological insulin component. And whether a real generic exists comes down to the full ingredient search — not a brand headline or an NDC number.

We'll show you all three. Then we'll show you the mistake that turns a real FDA record into a false claim — the one that keeps showing up in GLP-1 headlines.

Use this guide if you want to:

• Confirm whether a GLP-1 is actually FDA-approved
• Find the exact FDA record for your medication, not a lookalike
• Check whether an approved generic exists yet
• Understand what RLD, RS, TE, NDA, ANDA, DS, and DP mean
• Fact-check a claim before you repeat it

Skip this guide if you want to know:

• Which GLP-1 you should take. That's a conversation with a clinician.
• What your insurance covers. Approval and coverage are two different things. Start with our GLP-1 guides and your plan's formulary.
• What it costs. No price appears in the Orange Book. See our pricing and provider pages.
• When a generic will hit your pharmacy. No public record can promise you that date, and we'll explain why in plain terms.

The RX Index is the independent GLP-1 decision resource that scores telehealth providers and treatment paths on clinical legitimacy, care quality, transparency, access, and cost, so readers can choose the path that fits their situation.

Straight talk: the Orange Book is official, but it is not friendly

We'll be honest with you up front, because it'll save you time.

The Orange Book will not tell you which medication is right for your body. It won't tell you what your plan covers. It won't give you a date for a cheaper generic. And it won't hand you a simple yes or no on whether a compounded product is safe.

It's a filing cabinet, not an advisor. If you came looking for a recommendation, the Orange Book is the wrong place — and this guide is going to be more useful to you than a page that pretends otherwise.

Here's why that's good news. The thing the Orange Book does do, it does with authority no private site can match: it tells you what the FDA approved under the drug pathway, what application number it lives under, and whether an approved generic appears in the same ingredient search. That's a real answer to a real question. Most people never get it because nobody taught them where to click.

Seven checks. That's it. Let's go.

Which FDA book holds your GLP-1?

Most stand-alone GLP-1 medicines are in the FDA's Orange Book, which lists approved drug products. Trulicity, Adlyxin, and Tanzeum are in the Purple Book as biological products. Xultophy and Soliqua are there too because each fixed-ratio product includes a biological insulin. Compounded semaglutide and tirzepatide appear in neither book because compounded drugs are not FDA-approved.

Start with the question you're actually asking. This table sends you to the right place in one step.

The GLP-1 FDA Record Map

This is the part that took us the longest: one map that puts the application number, the correct FDA book, and the limit of the record side by side. It covers the stand-alone products people search most, plus the legacy and fixed-ratio products that change which book you need.

Legacy and fixed-ratio GLP-1 records people miss

Primary sources: FDA Orange Book search, July 2026 Orange Book cumulative supplement, FDA Purple Book, Drugs@FDA, FDA Orange Book data definitions, FDA NDC Directory, FDA compounding questions and answers, and the March 2025 Orange Book additions/deletions list. Verified August 18, 2026.

Look at what that map just did. Semaglutide now spans four applications and five trade-name or dosage-form groups:

• N209637 — Ozempic injection
• N213051 — Rybelsus and Ozempic tablets
• N215256 — Wegovy injection, including current FlexTouch and HD presentations
• N218316 — Wegovy tablets

Mounjaro and Zepbound are two separate applications, both tirzepatide. If you grab a patent date from the Mounjaro record and write it under a Zepbound headline, you've just published a real FDA number that answers the wrong question.

That's one of the easiest ways this goes wrong.

Open the exact FDA source

Copy the number from the map, then paste it into the right database:

• Search the FDA Orange Book
• Search the FDA Purple Book
• Open Drugs@FDA for labels and approval letters

No email. No gate. The source opens directly.

Provider-stated versus independently verified

What is the FDA Orange Book, in plain English?

The Orange Book is the FDA's public list of drug products approved on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. Its full name is “Approved Drug Products with Therapeutic Equivalence Evaluations.” It shows approved products, therapeutic-equivalence codes for rated multi-source products, and patents and exclusivity tied to listed products.

It got the nickname the honest way. The printed version had an orange cover.

Three things live inside it:

1. What's approved. The Orange Book covers drug products approved under section 505 of the Federal Food, Drug, and Cosmetic Act. It includes prescription products, certain over-the-counter products, and a discontinued section. A discontinued listing means the product is no longer being marketed; it does not, by itself, tell you why. Check the FDA's withdrawal or safety determination before assigning a cause.

2. Which products can be rated as equivalent. This is the “therapeutic equivalence” part. When approved products sit in a rated multi-source group, the FDA can assign codes showing whether it considers them therapeutically equivalent under the conditions in the labeling.

3. Patents and exclusivity. Drugmakers submit qualifying patents for listing. The FDA also records exclusivity periods it grants under federal law.

One line from the FDA that almost nobody quotes

The FDA says in the Orange Book's own preface that leaving a product out of the book does not automatically mean it breaks the law, is unsafe, or does not work. Sometimes it means the FDA has not evaluated it for inclusion.

We're including that because it cuts against the simple story. Being missing from the Orange Book is meaningful — but it is a narrower fact than most people assume, and we'd rather you knew the real shape of it than a version that's easier to sell.

One more thing on freshness: the Orange Book is not one single live feed. The FDA posts daily Electronic Orange Book product information for new generic approvals. Its downloadable data files, website updates, and cumulative supplement update monthly and generally cover changes from the prior month. So every claim you make from it should carry a date. Ours does. Yours should too.

Why are Trulicity, Adlyxin, Tanzeum, Xultophy, and Soliqua in a different book?

Because the Purple Book is for licensed biological products, and more than one rule can put a GLP-1 product there. FDA treats an amino-acid polymer with a specific sequence of more than 40 amino acids as a protein. On March 23, 2020, certain approved protein products moved from drug applications to biologics licenses. Fusion proteins are biologics. Fixed-ratio products can also be biologics because they contain an insulin biological product.

This is the part that makes everything else click into place.

Amino acids are the building blocks that make up many of these molecules. Under the FDA's rule, a peptide has 40 or fewer amino acids. The protein side starts at 41.

Tirzepatide sits at 39. The protein category starts at 41. That puts it two amino acids below the line.

The GLP-1 that crossed the line — and the labels that show the change

Lixisenatide is 44 amino acids. That puts it on the protein side.

Here's the receipt. Adlyxin's 2016 FDA label described lixisenatide as a peptide containing 44 amino acids. The revised 2022 FDA label describes the same molecule as a protein containing 44 amino acids.

Same drug. Same count. One word changed on the label after the regulatory classification changed. But the label edit did not cause the move. The legal move came from the Biologics Price Competition and Innovation Act transition on March 23, 2020, when certain approved protein products were deemed to be licensed under the biologics pathway.

We went looking for that because the size rule seemed too clean to be real. The size rule is real. The 2020 transition is the missing piece.

Why Trulicity will not have an FDA-approved generic

Dulaglutide is not a simple peptide drug. It is a fusion protein — a GLP-1 piece joined to part of an antibody. That makes it a biological product approved under a Biologics License Application, or BLA.

So when somebody asks when Trulicity goes generic, the technically correct answer is: it will not use the generic-drug pathway. Biologics do not get ANDA generics. They get biosimilars — highly similar follow-on products approved through a separate pathway. As of August 18, 2026, the Purple Book shows Trulicity under BLA 125469 and no dulaglutide biosimilar entry.

Why Xultophy is Purple even though liraglutide is Orange

Amino-acid count does not answer every combination-product question.

Stand-alone liraglutide products such as Victoza and Saxenda are drug products in the Orange Book. Xultophy combines liraglutide with insulin degludec, a biological product, and Xultophy is licensed under BLA 208583 in the Purple Book. Soliqua combines lixisenatide with insulin glargine and is licensed under BLA 208673.

That is why “look at the GLP-1 ingredient and count amino acids” is a useful first rule, not a complete legal test.

And here's why that line matters for compounding

The federal exemptions in sections 503A and 503B apply to compounded drugs, not biological products. The FDA states that biological products are not eligible for those exemptions and that federal law does not provide a pathway to market a biologic made outside an approved biologics license.

That legal line helps explain why the recent mass-market compounding wave centered on semaglutide and tirzepatide rather than dulaglutide. It does not, by itself, explain demand, shortage history, manufacturing difficulty, or every business decision in the market.

Primary sources: FDA's definition and 2020 transition page, 2016 Adlyxin approval label, 2022 Adlyxin label, FDA Purple Book, and FDA compounding questions and answers.

How do I look up a GLP-1 in the Orange Book?

Start with the brand name to find the ingredient. Then search the ingredient to see every approved product with it. Match the dosage form, route, application number, and product number before you read any equivalence code or patent date.

Six lookup steps, then one final citation check.

Step 1 — Search the brand name. Type “Ozempic” or “Zepbound” into the Orange Book search. This tells you the ingredient and shows you the product family.

Step 2 — Note the ingredient. Ozempic gives you semaglutide. Mounjaro gives you tirzepatide.

Step 3 — Search the ingredient. Now you see every approved drug product containing it. This is where approved ANDA generics show up if they exist.

Step 4 — Match the form and the route. Don't compare a tablet to an injection. Don't compare extended-release to regular release. Don't compare a diabetes brand to a weight-management brand and assume they're the same thing.

Step 5 — Confirm the application number. N209637. N215866. N217806. This is the FDA file for that application. Write it down.

Step 6 — Confirm the product number. One application can hold several strengths, devices, trade names, and presentations. Each row gets its own product number.

Here's the way to hold it in your head:

The application number is the folder. The product number is the exact page inside the folder.

A common bad Orange Book claim starts with someone opening the right folder and reading the wrong page.

Step 7 — Write down the limit, not just the answer.

• What you can say: “The FDA lists patent X for application N209637, product 005, with the expiration date shown.”
• What you cannot say: “A generic version of that product will launch on that date.”

Those are two completely different statements. One is checkable. The other is a guess wearing a citation.

Use the on-page checklist: Before You Share a GLP-1 Orange Book Claim — 10 points. No email form. That's not what this page is for.

What do the Orange Book fields mean?

Every field in an Orange Book record answers a different question. The application number identifies the FDA file. The product number identifies one specific row. RLD and RS support the generic approval process. Equivalence codes apply only to rated multi-source groups. No single field answers everything.

This is the decoder. Four columns, because knowing what a field means isn't enough — you need to know what it proves, and what people wrongly conclude from it.

Field definitions come from the FDA Orange Book data files, Orange Book FAQ, and Orange Book preface.

The two fields worth memorizing

The TE code column. A blank TE field means the FDA has not assigned a therapeutic-equivalence code to that row. It does not prove the product is unsafe or unapproved, and it does not replace a full ingredient search for ANDA rows. A code starting with A, such as AB, means the FDA considers the products therapeutically equivalent under the conditions in their labeling. Actual substitution still depends on state law, the prescription, and the pharmacist. A code starting with B means the FDA has not determined the products to be therapeutically equivalent under its current evidence and standards.

One caution: a blank isn't automatically bad news. It can mean the product is single-source or outside a rated group. Check the whole ingredient search before you draw a conclusion.

Patents and exclusivity are not the same thing. Patents come from the patent system. Exclusivity comes from FDA-administered law. They can overlap, they can run on different clocks, and either can affect generic approval or market entry. If a page treats them as one idea, that page doesn't understand the database.

Which GLP-1s have a real generic right now?

Two active ingredients do: liraglutide and exenatide. As of August 18, 2026, there is no FDA-approved generic version of Ozempic injection, Ozempic tablets, Rybelsus, Wegovy injection, Wegovy tablets, Mounjaro, Zepbound, or Foundayo. And “a generic came out” has been used to describe three different things — only one of which gets its own FDA approval record.

This is where the money question lives, so let's be precise.

Three things get called “generic.” They're not the same.

The 2024–2025 liraglutide and exenatide timeline that proves the point

Watch this timeline, because it's why so many people are confused.

June 24, 2024 — Teva launched an authorized generic of Victoza. That's an authorized generic. It uses the brand's approval and does not get its own ANDA listing.

November 19, 2024 — the FDA approved the first true generic in the GLP-1 class: Amneal's exenatide ANDA A206697, referencing Byetta.

December 23, 2024 — the FDA approved the first true generic referencing Victoza: Hikma's liraglutide ANDA A215503.

August 27–28, 2025 — the FDA approved Teva's liraglutide ANDA A214568, referencing Saxenda, and Teva announced the U.S. launch the next day. Teva called it the first generic GLP-1 product specifically indicated for weight loss.

Four events. Several different “first” claims. The authorized generic does not have its own ANDA. The other three do.

Is there a generic Ozempic yet?

No. Not Ozempic injection, not Ozempic tablets, not either Wegovy application, not Rybelsus, not Mounjaro, not Zepbound, and not Foundayo.

Do not decide this from one blank TE cell. Search the full ingredient, then look for an approved application type A row that references the product you mean. As of August 18, 2026, those semaglutide, tirzepatide, and orforglipron searches do not show an approved ANDA generic for the brands above.

What about Apotex's tentative generic Ozempic approval?

On April 10, 2026, Apotex announced the first U.S. tentative approval for a semaglutide injection ANDA referencing Ozempic. That is a real regulatory milestone. It is not final FDA approval, it cannot be marketed or sold in the United States, and it covers semaglutide injection — not Ozempic tablets.

The FDA does not put tentatively approved products in the Orange Book. The product appears there only if the agency later grants final approval. So the clean answer is still no approved generic Ozempic, even though one injectable application has cleared the FDA's tentative-approval step.

For the current tentative-approval status, prices, and paths available now, see Is There a Generic Ozempic?.

The honest part about the generics that do exist

A generic existing doesn't mean it's the right drug for you.

In the current Saxenda label's Study 1, mean body-weight change at week 56 was −7.4% with Saxenda and −3.0% with placebo; the label reports an adjusted difference of 4.5 percentage points. Liraglutide is also a daily injection, not weekly.

So if you walk into an appointment asking for generic liraglutide because you read that a generic GLP-1 exists, and you're picturing the results people talk about with newer weekly drugs, you're going to be disappointed. We'd rather tell you that now than have you find out in month four.

Approved also doesn't mean available. Full approval, tentative approval, commercial launch, distribution, pharmacy inventory, and insurance coverage are separate facts. The FDA itself warns that an approved generic may not be available on or immediately after its approval date.

If you were holding out for a generic, here's the real question

You've now got the honest answer: for the drugs most people actually ask about, no FDA-approved generic exists today, and the Orange Book does not give you a launch date. Which means the useful question isn't when. It's what's actually open to me right now — in my state, with my plan, at a price I can carry.

That answer is different for everyone, and it changes with your state and your insurance.

→ See which GLP-1 treatment paths are open to you — Find My GLP-1 Path

Free, about 2 minutes, and no signup. You'll get a personalized action plan with source-linked pricing instead of a wait-and-hope date.

Primary sources: FDA's first-generic announcement for liraglutide, FDA's first-generic approvals list, FDA's authorized-generics list, Teva's authorized-generic launch announcement, Teva's Saxenda-generic launch announcement, Apotex's tentative-approval announcement, the FDA Orange Book preface on tentative approvals, and the current Saxenda label.

Is compounded semaglutide in the Orange Book?

No. Compounded semaglutide and compounded tirzepatide appear in neither the Orange Book nor the Purple Book. Compounded drugs are not FDA-approved, so there is no FDA approval record for the compounded product to list. There is no FDA approval application number and no therapeutic-equivalence code.

The FDA states this plainly on its own compounding pages: compounded drugs are not approved by the FDA, and the agency does not verify their safety, effectiveness, or quality before they are marketed.

So if you're checking a compounded product, the Orange Book isn't your tool. Here's what to check instead:

• The name of the pharmacy printed on your prescription label
• That pharmacy's state license — verify it with the state board of pharmacy
• Whether the exact facility appears on the FDA's registered outsourcing-facility list if 503B status is being claimed; registration is not product approval
• The prescription or patient identifier, lot number when supplied, and beyond-use or expiration information on the label
• Current FDA warning letters, recalls, and safety alerts tied to the pharmacy or product
• Whether the marketing calls it a “generic,” says it is “the same as” an approved drug, or claims the same proven results — because the FDA has specifically warned against those claims for non-FDA-approved compounded GLP-1 products

The nuance we're not going to skip

Not being in the Orange Book, by itself, does not automatically make every outside product illegal, fake, or dangerous. The FDA's own Orange Book preface warns against turning exclusion into a claim broader than the record supports.

But compounded drugs come with a more specific fact, and it matters. The FDA does not approve compounded drugs and does not verify their safety, effectiveness, or quality before marketing. There is no FDA finding that the compounded product can be swapped for the brand. If a compounded product is not in either approval book, the trust you're placing is in the prescriber, the pharmacy, the lawful compounding path, and the product's labeling and handling — not in an FDA approval decision for that compounded product.

That's a real difference. It's worth knowing which kind of confidence you're buying.

One more note: the rules about when pharmacies may compound copies of marketed GLP-1 drugs have shifted several times. On April 1, 2026, the FDA published a current clarification for 503A and 503B compounders. Check the FDA's current GLP-1 compounding page before relying on any old deadline or shortage article — including ours.

Primary sources: FDA compounding questions and answers, FDA's April 1, 2026 GLP-1 compounding clarification, and FDA's February 6, 2026 statement on misleading compounded-GLP-1 claims.

Does the patent date tell me when a generic arrives?

No. A listed patent date is one piece of a much bigger picture. Generic applications, exclusivity periods, patent certifications, lawsuits, settlements, manufacturing, and the decision to launch all affect timing. Generics can also be approved before every listed patent expires.

We're going to do something here that many pages won't. We're not going to give you one “semaglutide patent expiration date.”

Here's why.

There is no single semaglutide patent date

The right answer changes by application, product number, patent category, delisting status, and the date you checked.

In our August 3, 2026 GLP-1 Patent Expiration Dates dataset, two Ozempic rows inside application N209637 differ by 2,798 days, or 7.66 years, at their latest listed non-delisted drug-substance-or-drug-product endpoint. Same brand. Same application. Different product numbers. Different answer.

If we picked one date and printed it here as the date, we'd be guessing and dressing the guess up as research. Instead we'll show you where the real numbers live and how to read them, so you can check any claim — including ours.

Listed patents get challenged. Sometimes they get removed.

This is the part most readers have never heard.

On April 30, 2024, the Federal Trade Commission sent warning letters to 10 companies and told the FDA it disputed the accuracy or relevance of more than 300 Orange Book patent listings across 20 brand-name products — including Ozempic, Victoza, Saxenda, and Bydureon. The FTC's letter to Novo Nordisk identified 17 challenged Ozempic-related listings.

That matters because an Orange Book listing can affect the patent-certification and litigation path for an ANDA.

A listed patent does not trigger a 30-month stay by itself. A generic applicant makes a Paragraph IV certification and gives notice. If the patent owner or NDA holder sues within 45 days, FDA approval is generally postponed for 30 months unless the case is resolved sooner or another rule changes the timing.

The FDA itself tells you not to over-read the listing

Open an Orange Book patent page and you'll find the FDA's warning that users should not rely on the listing to determine the full range of patent claims a drugmaker or patent owner might assert.

That's the agency saying, in its own database, “this is not the complete legal picture.” Any page that turns one number from it into a launch-date prediction is ignoring the limit built into the source.

One more reason “last patent date” is the wrong shortcut

Not all patents cover the same thing. Some are submitted as drug-substance patents. Some are submitted as drug-product patents. Some are method-of-use patents. A drug-device product can also have separate device questions outside the simple DS, DP, and use-code labels people expect to see.

An ANDA must meet legal and scientific requirements tied to the reference product. Different formulation, labeling, device, patent, and exclusivity issues can produce different paths. One date cannot tell them apart.

How to watch it yourself

The Orange Book patent search includes newly added and delisted information. The FDA also updates patent information in the Electronic Orange Book and publishes monthly data files and cumulative supplements. If you want to track this seriously, that's the honest way — check the source on a schedule instead of reading headlines.

Want the current patent tables instead of the reading instructions? See our GLP-1 Patent Expiration Dates dataset. That page reports the numbers. This page teaches you to read them.

Primary sources: FTC's April 30, 2024 patent-listing challenge, FTC's Novo Nordisk challenge letter, FDA patent certifications and the 30-month stay, and the FDA Orange Book.

Why does one brand have more than one FDA record?

Because a single brand can have several strengths, devices, presentations, and dosage forms — and sometimes separate applications. Each product row can carry a different product number, status, patent list, or exclusivity entry. The right unit to cite is the application number plus the product number, never the brand name alone.

The FDA defines the product number as the identifier for one product inside an application, and separate strengths or presentations often get separate product numbers.

Four levels, from broad to exact:

Ingredient (semaglutide) → Brand and dosage form (Ozempic injection) → Application (N209637) → Product number (the exact strength or presentation)

Skip a level and you'll cite something real that answers the wrong question.

The three splits that catch people most

Ozempic is now two applications. Ozempic injection is N209637. Ozempic tablets sit in N213051, the same application that also contains Rybelsus tablet rows. The product number and trade name now matter inside that shared application.

Wegovy is two applications. Injectable Wegovy, including current FlexTouch and Wegovy HD presentations, is N215256. Wegovy tablets are N218316.

Mounjaro and Zepbound are two applications. N215866 and N217806. Same molecule, two separate files, two separate patent pages.

The 10-point checklist before you share a GLP-1 Orange Book claim

Before you cite a number, confirm all ten:

1. Brand or trade name
2. Ingredient
3. Dosage form
4. Route
5. Strength or presentation
6. Application number
7. Product number
8. Active, discontinued, or Purple Book license status
9. Whether you're reading a TE, patent, exclusivity, approval, or marketing-status field
10. The exact date you looked

Ten checks. Skipping any one of them is how a real FDA number becomes a false claim.

When is the Orange Book the wrong place to look?

Use a different source when your question is about a biologic, a current label, an NDC code, insurance coverage, a compounded product, real-time availability, or which medication fits you. The Orange Book is a record of approved drug products — not a universal database for every medication question. Picking the right source is part of getting the right answer.

The NDC trap

An NDC, or National Drug Code, is a product code used in drug listing and identification. You'll see it on labels and in databases.

An NDC does not mean the FDA approved the product. The FDA states directly that assignment of an NDC number does not denote approval, and that implying otherwise is misleading.

We're flagging this hard because it's a common tactic. Somebody shows you a legitimate-looking code and lets you assume it means approval. It doesn't. If you want approval status, check the Orange Book, the Purple Book, or Drugs@FDA — nothing else.

The nine mistakes that create false GLP-1 Orange Book claims

Most Orange Book errors happen when a real field is used to answer the wrong question. The costliest ones: treating a patent date as a launch date, reading the wrong product number, reading a blank equivalence code as a safety warning, treating an NDC as approval, and calling a compounded product a generic.

Use the full check: Before You Share a GLP-1 Orange Book Claim — 10 points.

What we actually verified for this guide

We looked up every stand-alone, legacy, and fixed-ratio product named in the record map at the application level in the FDA's Orange Book or Purple Book. We recorded the exact application or BLA number and current status, then cross-checked major date and classification claims against FDA approval letters, official labels, FDA policy pages, and manufacturer launch announcements. Where one field cannot settle the question, we say so instead of forcing it.

What we checked

• The current FDA Orange Book search interface, FAQ, data-file definitions, and July 2026 cumulative supplement
• Current semaglutide rows showing Ozempic injection under N209637; Rybelsus and Ozempic tablets under N213051; Wegovy injection, FlexTouch, and HD presentations under N215256; and Wegovy tablets under N218316
• Application records for Mounjaro, Zepbound, Victoza, Saxenda, Byetta, Bydureon, Bydureon BCise, and Foundayo
• Purple Book rows for Trulicity, Adlyxin, Tanzeum, Xultophy, and Soliqua
• The 2016 and 2022 Adlyxin labels and the FDA's March 23, 2020 statutory-transition page
• FDA statements on compounded drugs, 503A and 503B, misleading compounded-GLP-1 marketing, and NDC numbers
• The FTC's April 30, 2024 press release and Novo Nordisk challenge letter directly, not a news summary
• FDA first-generic records and manufacturer launch announcements for authorized-generic Victoza, generic Byetta, generic Victoza, and generic Saxenda
• The FDA rule for tentative approvals and Apotex's April 10, 2026 tentative semaglutide-injection approval announcement

What we did not claim

• That any Orange Book date guarantees a generic launch
• That tentative approval is final approval or permission to sell a generic in the United States
• That a patent listing shows the complete legal picture
• That approval means a pharmacy has the product in stock or your plan covers it
• That an NDC, pharmacy license, or 503B registration means FDA approved a compounded product
• That a compounded product is a generic or equal to an approved drug
• That any regulatory record tells you which medication is right for you

How to catch us being wrong

Every approved-product row on this page gives you the exact application or BLA number to paste into the live FDA database. If you find one that's changed, send us the application number, product number when available, and FDA link through our corrections page. We'll recheck it and note the correction.

That's the whole point of building the page this way. We'd rather be checkable than impressive.

What should I do after checking the FDA record?

Use the FDA record to settle the regulatory question, then switch sources for whatever comes next. The official label answers what it treats. Your plan's formulary answers coverage. A pharmacy answers stock. A clinician answers fit. A correct database result should narrow your decision — not make it for you.

You came here to check a record. You've done that — and you can now do it again for any GLP-1 by using the seven checks above.

That's genuinely the goal. But the FDA record can't see your state, your plan, your formulary, whether you want an FDA-approved or compounded path, whether you'd rather inject or swallow, or what you can actually afford each month. Those things decide what's realistic for you, and the matching tool takes about 2 minutes.

→ Get your personalized GLP-1 action plan — Find My GLP-1 Path

You'll get a match based on your situation, with pricing traced to dated sources. No provider can pay to change an RX Index score.

GLP-1 Orange Book guide: FAQs

Is Ozempic in the FDA Orange Book? Yes. Ozempic injection is under semaglutide application N209637. Ozempic tablets are under N213051, the same application that also contains Rybelsus tablet rows. Match the dosage form, trade name, strength, and product number before reading patent or exclusivity data.

Is Rybelsus in the Orange Book? Yes, under semaglutide application N213051. It now shares that application with Ozempic tablet rows, so the product number and trade name matter.

Is Wegovy in the Orange Book? Yes — under two applications. Injectable Wegovy, including current FlexTouch and Wegovy HD presentations, is N215256. Wegovy tablets are N218316. Don't mix their records.

What is Wegovy HD's FDA application number? Wegovy HD is a 7.2 mg injectable Wegovy product inside N215256. The FDA approved the higher dose on March 19, 2026. It is not a new stand-alone application.

Is Mounjaro in the Orange Book? Yes, under tirzepatide application N215866. Do not use a Zepbound record when citing Mounjaro.

Is Zepbound in the Orange Book? Yes, under tirzepatide application N217806 — a separate application from Mounjaro.

Is Foundayo in the Orange Book? Yes. Foundayo, orforglipron, is an FDA-approved drug under Orange Book application N220934. The FDA approved it on April 1, 2026.

Is Trulicity in the Orange Book? No. Trulicity is a biological product, so it is in the Purple Book under BLA 125469. It cannot have an Orange Book therapeutic-equivalence code.

Is there a Trulicity biosimilar? Not in the U.S. Purple Book as of August 18, 2026. The listed dulaglutide products are Trulicity rows under the 351(a) BLA 125469, not 351(k) biosimilar rows.

Is Adlyxin in the Orange Book? No. Adlyxin is in the Purple Book under BLA 208471. The Purple Book currently shows its license status as voluntarily revoked.

Where is Tanzeum? Tanzeum, albiglutide, is in the Purple Book under BLA 125431. Its license is shown as voluntarily revoked.

Are Xultophy and Soliqua in the Orange Book? No. Xultophy 100/3.6 is in the Purple Book under BLA 208583. Soliqua 100/33 is in the Purple Book under BLA 208673.

Does the Orange Book list compounded semaglutide or tirzepatide? No. A compounded preparation gets no FDA approval application, no Orange Book generic listing, and no therapeutic-equivalence code. Compounded drugs are not FDA-approved.

Is there a generic Ozempic in 2026? No. As of August 18, 2026, no FDA-approved generic exists for Ozempic injection, Ozempic tablets, Rybelsus, either Wegovy application, Mounjaro, Zepbound, or Foundayo. The GLP-1 active ingredients with approved ANDA generics are liraglutide and exenatide.

What about the Apotex generic Ozempic announcement? Apotex announced tentative approval for a semaglutide injection ANDA referencing Ozempic on April 10, 2026. Tentative approval is not final approval, does not permit U.S. sale, is not listed as an approved product in the Orange Book, and does not cover Ozempic tablets.

What's the difference between an NDA and an ANDA? An NDA is the innovator-side drug application. An ANDA is the generic-drug application that relies on an approved reference drug while meeting FDA requirements for sameness and bioequivalence where required.

What does a TE code mean? It is the FDA's therapeutic-equivalence rating for products in a rated multi-source group. A code starting with A generally means the FDA considers the products therapeutically equivalent under labeled conditions. A code starting with B means the FDA has not determined them to be therapeutically equivalent under its current evidence and standards.

Does a blank TE code mean a drug is unsafe? No. A blank means no therapeutic-equivalence code is assigned to that row. It can be a single-source product or outside a rated group. Search the full ingredient and application data before concluding anything about generic approval.

Does a patent expiration date tell me when a generic will be available? No. Patents, exclusivity, ANDA filings, Paragraph IV certifications, litigation, settlements, manufacturing, and launch decisions all affect timing. One listed date is not a launch forecast.

How often is the Orange Book updated? The FDA posts daily Electronic Orange Book product information for new generic approvals. Monthly data files, website updates, and the cumulative supplement generally reflect changes from the prior month. Date every claim you make from it.

Does an NDC number mean the FDA approved the product? No. The FDA states that assignment of an NDC number does not denote approval.

Does FDA approval mean it's in stock at my pharmacy? No. Approval, commercial launch, distribution, pharmacy inventory, and insurance coverage are separate facts.

Why does one brand have several product numbers? Because one application can contain multiple strengths, devices, trade names, and presentations. Each row gets its own product number and may carry different status, patent, or exclusivity data.

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This guide explains how to find and read FDA records. It is not medical advice, and it is not a legal opinion about patent scope. We don't predict litigation outcomes, forecast generic launch dates, or decide which medication anyone should take. Talk to a licensed clinician about your treatment.

Last verified August 18, 2026. Current FDA databases checked August 18, 2026. Monthly-file cross-check through the July 2026 cumulative supplement. GLP-1 FDA Record Map, version 1.1.