FDA List of Authorized Generics: Where to Find the Official Database and How to Use It
When you're looking for a cheaper version of a brand-name drug, you might assume all generics are the same. But thereâs a special kind of generic thatâs actually made by the same company that makes the brand - and itâs not listed in the usual places. These are called authorized generics. Theyâre identical to the brand-name drug in active ingredient, strength, and dosage form - down to the same factory, same equipment, same quality control. The only difference? No brand name on the label. And if you want to know which ones exist, the only official source is the FDAâs public list.
What Exactly Is an Authorized Generic?
An authorized generic isnât just another generic drug. Itâs the exact same product as the brand-name version, but sold without the brand name. For example, if you take the brand-name drug CLEOCIN T 1% gel, the authorized generic version is chemically and physically identical - same active ingredient, same manufacturer, same production line. The only visible differences might be a different color, shape, or marking on the pill or tube. These are marketed under the original brandâs New Drug Application (NDA), not through the standard generic approval process (ANDA). Thatâs why they donât show up in the FDAâs Orange Book, which only tracks traditional generics approved under ANDA.
This matters because authorized generics enter the market faster than traditional generics. While a regular generic manufacturer has to wait for patent expiration and may get 180 days of exclusivity, the brand company can launch its own authorized generic immediately. This lets them compete directly with the first generic, often lowering prices - but sometimes just keeping them high enough to protect profits. According to a 2023 study in Health Affairs, over 850 authorized generics were launched in the U.S. between 2010 and 2019. Pfizer, Teva, and Viatris (formerly Mylan) are the top players, with Pfizer alone responsible for 47 authorized generics on the FDAâs list.
Where to Find the Official FDA List
The only place to find a complete, government-mandated list of authorized generics is on the FDAâs website. Go to: fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs. This page is updated quarterly, with the latest version published on October 10, 2025. The list is available as a downloadable PDF file, about 1.09 MB in size.
Each entry includes four key pieces of information:
- The brand name (trade name) of the drug
- The dosage form and strength (e.g., 50 mg/200 mcg tablet, 1% gel)
- The name of the brand company that manufactures the authorized generic
- The date the authorized generic first entered the market
For example, youâll find entries like:
- ACTIQ lozenges (1200 mcg) - Cephalon, LLC - entered September 26, 2006
- ARTHROTEC tablets (50 mg/200 mcg) - Pfizer Inc. - entered November 1, 2012
- CLEOCIN T topical gel (1%) - Pfizer - entered June 11, 2003
These arenât random examples. Theyâre actual products listed in the FDAâs official database as of October 2025. If youâre trying to find a cheaper version of a drug you take, this list is your starting point.
Why the FDA List Is Different From Other Drug Databases
Many people check the FDAâs Orange Book or Drugs@FDA when looking for generics. But those databases wonât help you find authorized generics.
The Orange Book lists drugs approved under ANDA - traditional generics - and gives them therapeutic equivalence codes (like AB1, BX). But authorized generics arenât approved under ANDA. Theyâre approved under the original NDA. So theyâre invisible in the Orange Book, even though theyâre therapeutically identical to the brand.
Drugs@FDA gives you broad info on approved drugs - brand, generic, OTC - but it doesnât tag or filter authorized generics. Youâd have to manually search through hundreds of entries to spot one.
The FDAâs authorized generics list is the only place that pulls together all these special products in one place. Itâs the only source that answers the question: âIs this drug being sold as a version of the brand, made by the brand?â
What the List Doesnât Tell You
Hereâs the catch: the FDA list is not a real-time inventory. Itâs a record of what companies reported in their annual reports. The FDA says clearly: âThe list may include only information that is included in an annual report.â And hereâs the big problem - it doesnât tell you if the drug is still on the market.
For example, the list might show that an authorized generic entered the market in 2018. But if the manufacturer stopped selling it in 2023, the FDA wonât remove it. Youâll see it as âactiveâ even though your pharmacy canât get it. Thatâs why pharmacists report that 5 out of 8 products listed on the FDAâs list arenât available through their wholesalers.
Another issue: the âDate Authorized Generic Entered Marketâ isnât the exact launch date. Itâs the year and quarter covered by the annual report when the company first reported it. So if a product launched in January 2024, but the company reported it in their December 2024 annual report, the FDA will list it as entering the market in 2024 - even if it was available for 11 months.
According to a 2023 survey by the National Community Pharmacists Association, 68% of independent pharmacists found the list âsomewhat or very difficultâ to use for actual purchasing decisions. Why? Because it doesnât show availability, pricing, or current suppliers.
How to Use the List in Real Life
If youâre a patient, you can use the FDA list to find out if an authorized generic exists for your brand-name drug. Then ask your pharmacist: âIs this available?â or âCan you get the authorized version?â Sometimes, itâs priced lower than the brand - and always cheaper than the original.
If youâre a pharmacist or pharmacy buyer, cross-reference the FDA list with the National Drug Code (NDC) Directory. Search the NDC for the product name and check if itâs active. Then check with your wholesaler for current stock. Many pharmacies use weekly NDC deactivation reports from major distributors like McKesson or AmerisourceBergen to track whatâs actually in stock.
For industry analysts, the list is a goldmine. It shows which brand companies are using authorized generics to compete. Pfizerâs 47 entries, Tevaâs 32, and Viatrisâs 28 tell you whoâs playing the game. Combine this with IQVIA sales data, and you can see how much market share these products capture during the 180-day exclusivity window.
Whatâs Coming Next
The FDA knows the current PDF list has limitations. In its 2025 Strategic Plan, CDER announced plans to replace the PDF with a dynamic, searchable database by mid-2026. Stakeholders - including pharmacists, manufacturers, and regulators - have been pushing for this for years. At a 2024 public meeting, 22 out of 28 participants asked for better search tools and real-time updates.
Thereâs also talk of linking the authorized generics list to the FDAâs Drug Shortage Portal and price transparency rules under the 2022 Inflation Reduction Act. That could mean future versions show not just whether a product exists, but whether itâs in stock and how much it costs.
But for now, the PDF is all youâve got. And while itâs not perfect, itâs the only official record of these hidden versions of your prescriptions.
Common Mistakes People Make
- Confusing authorized generics with traditional generics. Theyâre not the same. Only the FDA list shows authorized ones.
- Assuming the âentry dateâ means the product is still available. It doesnât.
- Using the Orange Book to search for authorized generics. You wonât find them there.
- Thinking the list shows pricing. It doesnât. Prices vary by wholesaler and pharmacy.
- Believing the list is complete. The FTC estimates 10-15% of authorized generics may be missing because companies donât always report them.
If youâre trying to save money on prescriptions, donât skip this list - but donât trust it blindly either. Use it as a starting point, then verify with your pharmacist or wholesaler.
Is the FDAâs authorized generics list free to access?
Yes, the FDAâs authorized generics list is completely free and publicly available on their website. No subscription, login, or payment is required. The PDF can be downloaded directly from the FDAâs authorized generics page.
Are authorized generics always cheaper than the brand-name drug?
Not always. While authorized generics are often priced lower than the brand, theyâre sometimes only slightly cheaper - sometimes even close to the brandâs price. Thatâs because the brand company is selling it themselves. In some cases, the authorized generic costs the same as the brand, just without the brand name. Itâs worth checking with your pharmacy, but donât assume itâs automatically the cheapest option.
Can I use the FDA list to find authorized generics for over-the-counter (OTC) drugs?
No. The FDAâs authorized generics list only includes prescription drugs approved under New Drug Applications (NDAs). OTC drugs are not covered. If youâre looking for generic versions of OTC products like ibuprofen or loratadine, those are traditional generics and are listed in the Orange Book or on pharmacy shelves under store brands.
Why donât authorized generics show up in the Orange Book?
The Orange Book only lists drugs approved under Abbreviated New Drug Applications (ANDAs), which are the standard pathway for traditional generic manufacturers. Authorized generics are approved under the original brandâs New Drug Application (NDA), so theyâre legally and technically considered the same product as the brand. The FDA keeps them in a separate list because they donât go through the ANDA process.
How often is the FDAâs authorized generics list updated?
The FDA is legally required to update the list quarterly. The most recent version as of January 2026 is dated October 10, 2025. Updates typically happen in January, April, July, and October. However, the list may not reflect real-time market changes - it only shows what companies reported in their annual reports.
Can I report a missing authorized generic to the FDA?
Yes. The FDA invites feedback and suggestions for additions or corrections. You can email them at [email protected]. However, the FDA can only include products that were reported by the manufacturer in their annual report. If a company didnât report it, the FDA wonât add it - even if itâs on the market.
Next Steps
If youâre a patient: Download the current FDA authorized generics list, find your drug, and ask your pharmacist if they carry the authorized version. It might save you money.
If youâre a pharmacy or wholesaler: Use the FDA list as a starting point, then cross-check with your NDC directory and wholesaler inventory reports. Donât rely on the FDA list alone to determine whatâs in stock.
If youâre a researcher or analyst: Combine the FDA list with IQVIA sales data or FTC reports to understand market dynamics. The FDA list shows whoâs launching authorized generics - commercial data shows how much theyâre selling.
The FDAâs authorized generics list isnât perfect, but itâs the only official record of these hidden versions of your prescriptions. Use it wisely - and always verify whatâs actually available before making decisions.
Maggie Noe
January 9, 2026 AT 07:29OMG I just found out my anxiety med is an authorized generic đ± Iâve been paying $80 for it and my pharmacist said the generic version is $12? I thought I was being scammed. Turns out itâs the SAME pill, just no brand name. Saved me $800 a year. Thank you for this post!! đđ
Darren McGuff
January 11, 2026 AT 05:48This is one of those posts that should be mandatory reading for every American on prescription meds. The FDAâs list is buried, underfunded, and poorly designed-but itâs the only real tool we have. Iâve been using it for years as a pharmacist in London, and I wish the NHS had something even half as transparent. The fact that Pfizer has 47 of these? Thatâs not competition-itâs market capture disguised as savings.
And yes, the PDF is a nightmare. I built a simple scraper to pull the data into a spreadsheet. Happy to share if anyone wants it.
Ashley Kronenwetter
January 13, 2026 AT 05:36While the information presented is accurate and valuable, I must emphasize the importance of verifying the status of authorized generics through official pharmacy channels. The FDAâs list, while authoritative, is not a real-time inventory system. Relying on it without cross-referencing with NDC databases or wholesaler catalogs may lead to erroneous conclusions regarding drug availability.
Heather Wilson
January 13, 2026 AT 09:49Letâs be real-this whole system is a joke. Big Pharma creates a brand-name drug, waits for the patent to expire, then launches their own âgenericâ version to crush the real generic manufacturers who actually invested in approval. The FDAâs list? A PR stunt. It doesnât show pricing, stock, or even if the product is still being made. And youâre telling patients to trust this? 68% of pharmacists say itâs useless, and youâre acting like itâs gospel? This isnât transparency-itâs obfuscation with a government seal.
Also, âauthorized genericâ is just a euphemism for âweâre still milking you, but now weâre the one selling it.â
Jeffrey Hu
January 15, 2026 AT 01:10Actually, youâre all missing the bigger picture. Authorized generics arenât even the main issue-itâs the ANDA exclusivity loophole that lets one generic company monopolize the market for 180 days while the brand sits back and waits. The FDAâs list doesnât even mention that. Iâve analyzed 1,200+ NDA entries since 2020, and Pfizerâs strategy is textbook: launch authorized generic on day one, undercut the real generic, then raise prices after exclusivity ends. Itâs anticompetitive by design. The FTC should be investigating this, not just publishing PDFs.
Matthew Maxwell
January 16, 2026 AT 03:47Itâs disgusting how people treat healthcare like a shopping mall. You think youâre saving money by switching to a generic? Youâre just enabling a system where corporations profit off your desperation. The fact that youâre excited about an âauthorized genericâ shows how little you understand the corruption in this industry. The brand company is still the same entity. The pill hasnât changed. The greed hasnât changed. Youâre just being sold the illusion of choice.
Kiruthiga Udayakumar
January 16, 2026 AT 20:05Iâm from India and we donât have this mess here. Generic drugs are cheap, real generics, not this âauthorizedâ nonsense. Why does the US make everything so complicated? My cousin takes the same medicine as you, costs $2, no brand, no PDF, no confusion. Just buy it. Why do you need a 10-page guide to get a pill? This is why healthcare is broken.
Patty Walters
January 18, 2026 AT 02:21soooo⊠if i look up my blood pressure med on the fda list and itâs there, does that mean my pharmacy CAN get it? or do i still have to beg them? iâve had this happen twice where they said âitâs on the listâ but then said âwe donât carry itâ⊠like wtf? also, the pdf is so hard to search, i keep misspelling âarthrotecâ and get nothing. đ
Jenci Spradlin
January 19, 2026 AT 09:31biggest tip: copy the brand name, paste it into the NDC directory, then cross-check with your wholesalerâs weekly deactivation list. i do this every monday. the fda list is a starting point, not the finish line. also, if youâre on medicaid, ask for the authorized version-sometimes itâs coded as âpreferredâ and you pay $0. just say âis there a version made by the same company?â theyâll know what you mean.
Gregory Clayton
January 20, 2026 AT 22:10THIS IS WHY AMERICA IS RUINED. Big Pharma owns the FDA. They write the rules, they control the list, and they let you think youâre getting a deal. Meanwhile, real generic companies get crushed. And youâre all acting like this is some kind of win? Wake up. This isnât transparency-itâs corporate control with a smiley face. If youâre not mad, youâre not paying attention.
Catherine Scutt
January 21, 2026 AT 09:30My mom spent $200/month on her heart med until I found the authorized generic. Now she pays $18. But the pharmacist didnât even know it existed until I showed her the FDA list. So⊠thanks? I guess? Still feels like weâre playing a rigged game.
Alicia Hasö
January 22, 2026 AT 13:27For anyone feeling overwhelmed-this is your moment to take control. You donât need to be a pharmacist or a data scientist. Just download the PDF, open it in your browser, hit Ctrl+F, type your drug name. If itâs there, walk into your pharmacy and say: âI saw this on the FDAâs authorized generics list. Can you get it?â Nine times out of ten, theyâll say yes. And if they donât? Ask them to order it. Your voice matters. Your health matters. Donât let bureaucracy make you feel powerless. Youâre not just a patient-youâre an advocate.
Meghan Hammack
January 24, 2026 AT 05:42Just wanted to say-this post saved me. I was on brand-name Lipitor for 3 years. $150/month. Found the authorized generic on the FDA list. Asked my pharmacist. Got it for $12. I cried. Not because Iâm emotional (okay, maybe a little), but because I finally felt like someone was looking out for me. Thank you for making this so clear. Youâre not just sharing info-youâre giving people back their power.