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 there’s a special kind of generic that’s actually made by the same company that makes the brand - and it’s not listed in the usual places. These are called authorized generics. They’re 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 FDA’s public list.

What Exactly Is an Authorized Generic?

An authorized generic isn’t just another generic drug. It’s 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 brand’s New Drug Application (NDA), not through the standard generic approval process (ANDA). That’s why they don’t show up in the FDA’s 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 FDA’s list.

Where to Find the Official FDA List

The only place to find a complete, government-mandated list of authorized generics is on the FDA’s 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, you’ll 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 aren’t random examples. They’re actual products listed in the FDA’s official database as of October 2025. If you’re 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 FDA’s Orange Book or Drugs@FDA when looking for generics. But those databases won’t 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 aren’t approved under ANDA. They’re approved under the original NDA. So they’re invisible in the Orange Book, even though they’re therapeutically identical to the brand.

Drugs@FDA gives you broad info on approved drugs - brand, generic, OTC - but it doesn’t tag or filter authorized generics. You’d have to manually search through hundreds of entries to spot one.

The FDA’s authorized generics list is the only place that pulls together all these special products in one place. It’s the only source that answers the question: “Is this drug being sold as a version of the brand, made by the brand?”

What the List Doesn’t Tell You

Here’s the catch: the FDA list is not a real-time inventory. It’s a record of what companies reported in their annual reports. The FDA says clearly: “The list may include only information that is included in an annual report.” And here’s the big problem - it doesn’t 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 won’t remove it. You’ll see it as “active” even though your pharmacy can’t get it. That’s why pharmacists report that 5 out of 8 products listed on the FDA’s list aren’t available through their wholesalers.

Another issue: the “Date Authorized Generic Entered Market” isn’t the exact launch date. It’s 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 “somewhat or very difficult” to use for actual purchasing decisions. Why? Because it doesn’t show availability, pricing, or current suppliers.

How to Use the List in Real Life

If you’re 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: “Is this available?” or “Can you get the authorized version?” Sometimes, it’s priced lower than the brand - and always cheaper than the original.

If you’re 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 it’s 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 what’s actually in stock.

For industry analysts, the list is a goldmine. It shows which brand companies are using authorized generics to compete. Pfizer’s 47 entries, Teva’s 32, and Viatris’s 28 tell you who’s 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.

What’s 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.

There’s also talk of linking the authorized generics list to the FDA’s 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 it’s in stock and how much it costs.

But for now, the PDF is all you’ve got. And while it’s not perfect, it’s the only official record of these hidden versions of your prescriptions.

Common Mistakes People Make

• Confusing authorized generics with traditional generics. They’re not the same. Only the FDA list shows authorized ones.
• Assuming the “entry date” means the product is still available. It doesn’t.
• Using the Orange Book to search for authorized generics. You won’t find them there.
• Thinking the list shows pricing. It doesn’t. Prices vary by wholesaler and pharmacy.
• Believing the list is complete. The FTC estimates 10-15% of authorized generics may be missing because companies don’t always report them.

If you’re trying to save money on prescriptions, don’t skip this list - but don’t trust it blindly either. Use it as a starting point, then verify with your pharmacist or wholesaler.

Next Steps

If you’re 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 you’re a pharmacy or wholesaler: Use the FDA list as a starting point, then cross-check with your NDC directory and wholesaler inventory reports. Don’t rely on the FDA list alone to determine what’s in stock.

If you’re a researcher or analyst: Combine the FDA list with IQVIA sales data or FTC reports to understand market dynamics. The FDA list shows who’s launching authorized generics - commercial data shows how much they’re selling.

The FDA’s authorized generics list isn’t perfect, but it’s the only official record of these hidden versions of your prescriptions. Use it wisely - and always verify what’s actually available before making decisions.