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

When you’re looking for a cheaper version of a brand-name drug, you might think of generic pills. But there’s another kind of generic that’s often overlooked: authorized generics. These aren’t just copies-they’re the exact same drug as the brand name, made by the same company, just sold without the brand label. And if you’re trying to save money on prescriptions, knowing where to find the official list of these drugs can make a big difference.

What exactly is an authorized generic?

An authorized generic is a brand-name drug that’s sold under a different label, usually at a lower price. It’s made by the original manufacturer, using the same ingredients, same factory, same packaging-except the brand name is removed. For example, if you take ACTIQ a fentanyl lozenge for breakthrough cancer pain, originally marketed by Cephalon, LLC, the authorized generic version is physically identical but labeled as just "fentanyl citrate". The FDA says these are "the same as the brand-name drug but does not use the brand name on the label."

Unlike regular generics, which are made by other companies after the patent expires and approved through an Abbreviated New Drug Application (ANDA), authorized generics are sold under the original company’s New Drug Application (NDA). That means they don’t appear in the FDA’s Orange Book, which lists approved generics and their therapeutic equivalence ratings. Instead, they’re tracked separately-on the FDA’s List of Authorized Generics.

Why does this list even exist?

The list wasn’t created to help patients save money. It was created because of a law. In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act (MMA). Section 505(t) of that law forced the FDA to publish a public list of all authorized generics, including:

• The brand name
• The company that makes it
• The date the authorized generic entered the market

The goal? To increase transparency. Brand manufacturers often launch their own authorized generic right before a regular generic hits the market. This lets them keep some market share-and sometimes even undercut the competition. The FDA’s list helps regulators, researchers, and pharmacies see who’s doing what.

Between 2010 and 2019, over 850 authorized generics launched in the U.S., according to a 2023 Health Affairs study. Pfizer alone has 47 on the list. Teva and Viatris (formerly Mylan) aren’t far behind. That’s not small change. It’s a major part of how drug pricing works behind the scenes.

Where do you find the official FDA list?

The only official source is the FDA’s own website: fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs. That’s the only page that links to the current PDF version of the list.

The list is updated every three months, with the most recent version dated October 10, 2025. It’s a single PDF file, about 1.09 MB, with columns for brand name, dosage, strength, manufacturer, and the date the authorized generic entered the market.

Here’s what you’ll see on the list:

• ARTHROTEC 50 mg/200 mcg tablets by Pfizer Inc., entered the market November 1, 2012
• CLEOCIN T 1% gel and lotion by Pfizer, entered June 11, 2003 and June 18, 2003

But here’s the catch: that date isn’t the exact day the drug hit shelves. It’s the date the company reported it in their annual FDA report. The FDA admits they don’t know the real launch date in most cases. And worse-they don’t know if the drug is still being sold.

Why the list isn’t enough for real-world use

Many people think if a drug is on the FDA’s list, it’s available at their pharmacy. That’s not true.

A 2023 survey of 1,247 independent pharmacists found that 68% found the list "somewhat or very difficult" to use for buying drugs. Why? Because the list doesn’t tell you:

• If the drug is still being manufactured
• Which wholesaler sells it
• What the current price is
• Whether your insurance covers it

One pharmacy owner in Ohio checked eight authorized generics from the list. Five weren’t available through his suppliers, even though the FDA said they entered the market in 2020. Another pharmacist on Reddit said, "The list is great for academic research but nearly useless for daily practice."

Companies like IQVIA and Symphony Health track actual sales and distribution. They know which authorized generics are still in stock, which ones are discontinued, and what pharmacies are ordering. But those services cost money. The FDA’s list? Free. But incomplete.

How to actually find an authorized generic you can buy

If you’re a patient or caregiver trying to save money, here’s what works:

1. Go to the FDA’s authorized generics page and search for your brand-name drug.
2. Write down the manufacturer’s name and the exact strength.
3. Call your pharmacy and ask: "Do you carry the authorized generic of [brand name]?" Give them the manufacturer name.
4. If they don’t have it, ask if they can order it. Authorized generics often come from specialty distributors.
5. Check the National Drug Code (NDC) Directory to match the manufacturer’s NDC number with the product.

For example, if you’re taking Propecia 1 mg finasteride tablets by Merck, the authorized generic is made by Merck too, but labeled as "finasteride 1 mg." The NDC number will be different from the brand version. Your pharmacist can look that up.

Don’t rely on online pharmacy lists or price comparison sites. Many don’t distinguish between authorized generics and regular generics. You could end up paying more than you need to.

What’s changing in 2026?

The FDA knows the PDF list is outdated. In their 2025 Strategic Plan, they said they’re building a searchable, dynamic database-expected to launch in Q2 2026. That means you’ll be able to search by drug name, manufacturer, or date, and possibly see real-time status (if it’s still on the market).

But even then, it won’t show pricing or availability. Those details still live with wholesalers and insurers. The FTC has also raised alarms: their analysis suggests 10-15% of authorized generics aren’t even reported to the FDA because companies don’t have to. There’s no penalty for forgetting to report.

Who benefits the most from authorized generics?

Not always the patient.

Harvard’s Dr. Aaron Kesselheim found that many authorized generics are priced only slightly lower than the brand name-sometimes just 5-10% cheaper. That’s not enough to make a real difference for someone paying out-of-pocket.

But for insurance companies and pharmacy benefit managers? Big savings. Authorized generics don’t trigger the 180-day exclusivity period that regular generics do. So if a brand company launches its own generic, it can block a cheaper competitor from dominating the market. That’s why companies like Pfizer and Teva use them as a business strategy.

For patients, the real win comes when you combine the FDA list with a good pharmacy. If your pharmacist knows to ask for the authorized version-and you’re willing to pay cash-you can often get the same drug for half the price of the brand.

What to do if the drug isn’t on the list

Just because a drug isn’t on the FDA’s authorized generics list doesn’t mean there’s no cheaper version. Many brand-name drugs have regular generics approved through ANDAs. Those appear in the Orange Book.

If you can’t find an authorized generic, check:

• The Orange Book for regular generics
• Drugs@FDA for all approved versions
• Your pharmacy’s discount program (like GoodRx or SingleCare)

And if you’re still unsure, ask your pharmacist to check the NDC Directory. They can tell you if a version exists-even if it’s not labeled as "authorized.""

If you’re trying to cut drug costs, the FDA’s authorized generics list is a starting point-not the finish line. Use it to ask smarter questions. Then work with your pharmacist to find the best price. That’s how you actually save money.