Chris Gore

FDA List of Authorized Generics: Where to Find and How to Use It

FDA List of Authorized Generics: Where to Find and How to Use It

If you're trying to find a cheaper version of a brand-name drug and heard about authorized generics, you're not alone. Many people assume all generic drugs are the same-but they’re not. Some generics are made by the original brand company and sold under a different label. These are called authorized generics. They’re chemically identical to the brand drug, but often cost less. The problem? Finding them isn’t easy. The FDA keeps a list, but it’s not simple to use. Here’s how to find it, what it actually tells you, and why it might not help you buy the drug you need.

What Exactly Is an Authorized Generic?

An authorized generic is the exact same drug as the brand-name version-same active ingredient, same dose, same shape, same manufacturer. The only difference? It doesn’t carry the brand name on the label. For example, if you take Cipro (brand), an authorized generic version might be sold as just "ciprofloxacin" but made by Bayer, the original maker. It’s not a copy. It’s the real thing, just repackaged.

This isn’t the same as a regular generic. Regular generics are made by other companies after the brand patent expires. They have to prove they work the same way, but they’re not made by the original company. Authorized generics skip that process entirely. They’re produced under the brand’s own FDA approval (called an NDA), not the generic approval (ANDA). That means they hit the market faster and without the 180-day exclusivity period that regular generics get.

Why does this matter? Because if you’re looking for the lowest price, an authorized generic can be cheaper than the brand, but not always cheaper than a regular generic. And sometimes, it’s not even available-despite being listed.

Where to Find the Official FDA List

The FDA publishes the only official list of authorized generics on its website. Go to fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs. That’s the only place that’s legally required to be accurate.

The list comes as a downloadable PDF-about 1.09 MB. It’s not a searchable website. It’s a static document updated every three months. The most recent version as of October 10, 2025, includes over 850 entries dating back to 1999. Each line shows:

  • The brand name (like ACTIQ, ARTHROTEC, CLEOCIN T)
  • The dosage form and strength (e.g., 1200 mcg lozenge, 50 mg/200 mcg tablet)
  • The company that makes it (usually the brand manufacturer-Pfizer, Teva, Mylan/Viatris)
  • The date the authorized generic entered the market

But here’s the catch: that "date entered the market" isn’t the exact day the drug went on sale. It’s the date range covered by the company’s annual report to the FDA. Companies don’t have to report the exact launch date. They just report that it happened sometime during the year. So if you see a drug listed with a 2023 date, it could’ve been available in January 2023-or December 2023.

Why the FDA List Doesn’t Tell You What You Really Need to Know

The FDA list tells you what was reported. It doesn’t tell you what’s currently being sold.

Pharmacists and patients have been frustrated by this for years. In a 2023 survey of 1,247 independent pharmacists, 68% said the list was "somewhat or very difficult" to use for actual purchasing decisions. Why? Because:

  • Many drugs listed are no longer on the market
  • The list doesn’t say if the drug is available at your pharmacy
  • It doesn’t show pricing
  • It doesn’t tell you if the manufacturer still makes it

One pharmacist in Ohio checked eight authorized generics listed by the FDA. Five weren’t available through any of his suppliers-even though the FDA showed they entered the market in 2024. He called the manufacturers. Three had stopped making them months earlier. The list didn’t reflect that.

Even the FDA admits this. Their own disclaimer says: "FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased."

So if you’re using this list to find a cheaper option for your prescription, you’re working with outdated information. It’s like checking a restaurant’s menu from 2020 and showing up expecting the same dish.

A crumbling FDA list made of sugar skulls drops pills as a patient and pharmacist compare it to a digital price screen.

How Authorized Generics Are Used in the Market

Brand-name drug companies don’t make authorized generics to help you save money. They do it to protect their profits.

When a brand drug’s patent expires, a generic company can launch and get 180 days of exclusive sales. During that time, they can charge high prices. But if the brand company launches its own authorized generic right away, it splits the market. The generic company can’t charge as much because now there’s a second low-cost option-even if it’s made by the same company.

This strategy is so common that 30% of brand drugs facing generic competition now have an authorized generic version, according to 2024 IQVIA data. Pfizer, Teva, and Viatris (formerly Mylan) are the top three companies launching them. In the 2025 FDA list, Pfizer has 47 authorized generics listed, Teva has 32, and Viatris has 28.

But here’s the irony: because these authorized generics are made by the brand company, they often cost more than regular generics. A 2020 JAMA Internal Medicine study found that many authorized generics are priced only slightly below the brand drug-sometimes just 5-10% cheaper. That’s not a big savings for patients.

On the other hand, some experts say they help prevent price gouging. When a generic company has exclusivity, they might jack up prices. An authorized generic can act as a check on that.

How to Actually Find and Buy an Authorized Generic

Don’t rely on the FDA list alone. Use it as a starting point, then verify with other tools:

  1. Check the National Drug Code (NDC) Directory at fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. Search by the generic name or NDC number. This will tell you which companies currently make and distribute the drug.
  2. Use a commercial database like IQVIA or RedBook if you have access (many pharmacies do). These show real-time availability and pricing.
  3. Ask your pharmacist to check their wholesaler’s catalog. They can tell you what’s in stock, not just what was reported.
  4. Compare prices on GoodRx or SingleCare. Sometimes the authorized generic shows up there-even if the FDA list doesn’t mention it.

For example, let’s say you’re looking for a generic version of Arthrotec. The FDA list says Pfizer launched an authorized generic in November 2012. But when you check GoodRx, you see two options: one made by Pfizer (authorized generic) at $12 for 60 tablets, and another made by a different company (regular generic) at $8. The FDA list doesn’t tell you that. The price comparison does.

Skeleton pharmacists sell pills at a vibrant Day of the Dead market with price tags and glowing NDC codes floating nearby.

What’s Coming Next

The FDA knows the current list is outdated. In its 2025 Strategic Plan, the agency says it plans to replace the PDF with a searchable, real-time database by mid-2026. That’s a big step forward.

They’re also working with the FTC to improve reporting. Right now, companies aren’t punished for forgetting to report an authorized generic. The FTC estimates 10-15% of them are missing from the list. That could change if new rules are passed.

There’s also talk of linking the authorized generics list to the FDA’s Drug Shortage Portal and the price transparency rules from the 2022 Inflation Reduction Act. That would mean future versions might show not just if a drug was made-but if it’s in stock, and how much it costs.

For now, though, the system is still broken. It’s useful for researchers, insurance companies, and big pharmacies. But for the average person trying to save money on a prescription? It’s more of a historical record than a shopping guide.

Bottom Line

The FDA’s list of authorized generics is the only official source for this information. But it’s not a tool for buying drugs. It’s a tool for understanding how the market works. If you want to find a cheaper version of your medication, use the list to identify possible candidates, then verify availability and price with your pharmacist or a price-comparison site.

Don’t assume a drug on the list is available. Don’t assume it’s the cheapest option. And don’t assume the FDA knows what’s happening right now. The system is designed for transparency-not convenience.

But if you’re a patient, a pharmacist, or a caregiver, knowing this list exists-and how to use it correctly-can help you ask the right questions. And sometimes, that’s the first step to saving money on your meds.

Comments (11)
  • Bobbi Van Riet

    I used to think generics were all the same until my mom started taking that blood pressure med and we realized the authorized generic from Pfizer was literally the exact same pill, just no brand name on it. She saved like $40 a month. But yeah, finding it? Total nightmare. The FDA list is like a library catalog from 1998-useful if you know how to read it, but useless if you just want to buy the damn thing.

    I started using GoodRx religiously after that. Even if the FDA says it’s available, I check the NDC code on the pharmacy’s website first. If it’s not showing up there, it’s not in stock. Simple as that.

    Also, pharmacists? They’re your real secret weapon. Ask them to call their wholesaler. Most of them don’t even know the FDA list exists, but they know what’s on the truck this week.

  • Holly Robin

    THE FDA IS LYING TO YOU. THIS IS A BIG PHARMA COVER-UP. THEY WANT YOU TO THINK YOU’RE SAVING MONEY BUT THE ‘AUTHORIZED GENERICS’ ARE JUST BRAND DRUGS WITH A NEW LABEL SO THEY CAN STILL CHARGE $100 WHILE YOU THINK YOU’RE GETTING $10. THEY’RE USING THE FDA LIKE A SHIELD WHILE THEY PRICE GAUGE YOU INTO BANKRUPTCY.

    I FOUND A PILL THAT SAID ‘CIPROFLOXACIN’ BUT THE BATCH CODE MATCHED BAYER’S BRAND PACKAGE. THEY’RE THE SAME COMPANY. THEY’RE TRICKING YOU. THIS IS WHY WE NEED A REVOLUTION.

  • Amy Insalaco

    It’s fascinating how the regulatory architecture of the NDA/ANDA dichotomy creates this artificial market segmentation-authorized generics function as a predatory entry mechanism designed to preempt the 180-day exclusivity window granted under the Hatch-Waxman Act. The FDA’s static PDF is an anachronism in a digital age, and its failure to integrate real-time market data reflects a systemic institutional inertia.

    Moreover, the lack of dynamic NDC synchronization between the FDA’s database and commercial pharmacy networks (e.g., RedBook, First Databank) creates informational asymmetry that disproportionately disadvantages low-income patients. The absence of price transparency mandates within the authorized generic reporting framework constitutes a regulatory blind spot that undermines the very premise of market competition.

    Frankly, if you’re relying on this list to make purchasing decisions, you’re operating with pre-2010 market intelligence. You need to cross-reference with CMS’s Drug Pricing Dashboard and the 340B database if you’re even remotely serious about cost optimization.

  • Beth Beltway

    People still fall for this? The FDA list is a joke. I work in pharmacy benefit management. We’ve been screaming for years that this thing is a relic. Companies don’t update it. They don’t even have to. And guess what? The ones who do? They’re the ones who stopped making the drug three months ago and just filed paperwork to cover their asses.

    I’ve seen patients get denied coverage because their insurer’s system pulls from the FDA list-and the drug isn’t listed anymore. So they say ‘no coverage’ even though the drug is still being manufactured and sold. This isn’t transparency. This is bureaucratic sabotage.

    And don’t even get me started on how Pfizer uses authorized generics to crush smaller generic manufacturers. It’s antitrust behavior disguised as consumer savings. The FDA knows this. They just don’t care.

  • Marc Bains

    Hey, if you’re new to this whole generic thing, don’t stress. I’ve helped a lot of folks in my community navigate this mess. The key is to not trust the list alone. Use GoodRx, ask your pharmacist to check their wholesaler, and if you’re on Medicare, call your plan’s customer service-they often have access to real-time formulary data.

    Also, if you see an authorized generic listed, ask the pharmacist: ‘Is this still being made? And is it cheaper than the other generic?’ Most of them will tell you the truth. They’re not paid to lie.

    And if you’re worried about quality? Authorized generics are the real deal. Same factory, same pill. Just no fancy logo. You’re not getting a knockoff-you’re getting the same thing for less. That’s not a scam. That’s capitalism working right.

  • kate jones

    The FDA’s authorized generic list is a legally mandated disclosure tool-not a consumer purchasing guide. Its purpose is to satisfy statutory reporting obligations under 21 CFR 314.94 and 21 CFR 314.127, not to facilitate real-time market transparency. The absence of dynamic updates, pricing data, and discontinuation notifications is not negligence-it’s a structural limitation of the current regulatory framework.

    For clinical and economic decision-making, the NDC Directory remains the authoritative source for active manufacturers and distributors. Supplementing this with commercial databases like Micromedex or RedBook is standard practice in pharmacy informatics. The disconnect between regulatory reporting and market reality is well-documented in peer-reviewed literature (e.g., JAMA Intern Med 2020;180:1021–1029).

    Patients should be empowered to ask pharmacists for the NDC number and verify it against the NDC Directory. That’s the only reliable method.

  • Sidhanth SY

    Man, I’m from India and we don’t even have this kind of list. We just go to the local chemist and ask for the cheapest one. Sometimes it’s the same pill, sometimes not. But here you got all this paperwork and still can’t find the damn thing.

    I think the real problem isn’t the list-it’s that drug prices are insane everywhere. Maybe we need to fix the price, not the list.

  • Adarsh Uttral

    bro the fda list is a pdf?? like… why??

    i just use goodrx and it tells me what’s cheap and where. why do i need to download a 1mb file and scroll through 800 drugs? that’s not helpful, that’s a headache.

    also why does it say ‘entered market 2023’ when i know the pill was gone by june? someone’s not updating this.

    just make a website. please.

  • Sheila Garfield

    It’s wild how something meant to help people ends up being so confusing. I showed my dad the FDA list last week and he just stared at it like it was ancient hieroglyphs. He’s 72, on a fixed income, just wants to know which pill costs less.

    I think the real win here is asking your pharmacist. They’re the ones holding the keys. The FDA can update their site all they want-if the local pharmacy doesn’t stock it, it doesn’t matter.

    Also, side note: I’ve had better luck with mail-order pharmacies than local ones. Weird, right?

  • Shawn Peck

    STOP USING THE FDA LIST. IT’S A TRAP. THEY PUT IT OUT SO YOU THINK YOU’RE BEING SMART WHEN YOU’RE JUST GETTING SCAMMED. THE REAL CHEAP ONES AREN’T EVEN ON THERE. JUST USE GOODRX. IT’S FREE. IT WORKS. DONE.

  • Niamh Trihy

    Just to add-authorized generics are often available through 340B pharmacies if you’re eligible. I’ve seen patients save 60-70% by using those. The FDA list doesn’t mention 340B status, but if you’re low-income or on Medicaid, it’s worth asking your provider. Many hospital-based pharmacies carry them and don’t advertise it.

    Also, if you’re on a Medicare Part D plan, check your plan’s formulary tier. Sometimes the authorized generic is on a lower tier than the regular generic, even if it costs more. That’s because of rebate structures-not price.

    Knowledge is power, but only if you know where to look.

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