Every year, millions of people around the world take prescription meds without knowing if what’s in their bottle is real. In the U.S., the FDA runs a set of public databases that can help you check if a drug is legitimate - but most people don’t know they exist. These aren’t fancy apps or websites designed for consumers. They’re tools built for pharmacies, distributors, and manufacturers. But if you know how to use them, you can verify your own medications and avoid dangerous counterfeits.
What the FDA Actually Tracks
The FDA doesn’t just approve drugs - it tracks every single approved medication sold in the U.S. through a system called the National Drug Code (NDC) Directory. This is the core database you need to know. Every prescription and over-the-counter drug has a unique 10- or 11-digit NDC number. It’s broken into three parts: the labeler code (who makes it), the product code (what the drug is), and the package code (how it’s packaged - like 30 pills vs. 100).
This isn’t just a list. It’s updated daily. If a drug gets pulled from the market, removed from approval, or relabeled, the NDC Directory reflects it within 24 hours. That means if you find a drug with an NDC that doesn’t show up here, it’s not legally approved in the U.S. - and it might be fake.
How to Check a Drug’s Legitimacy
Here’s how to use the NDC Directory step by step:
- Find the NDC number on the drug packaging. It’s usually printed near the barcode, often labeled "NDC" or just listed as a 10- or 11-digit number.
- Go to the FDA’s NDC Directory at accessdata.fda.gov/scripts/cder/ndc/.
- Enter the full NDC number in the search box. You don’t need to format it - just paste it as-is.
- Look at the results. If you see the drug name, manufacturer, dosage, and active ingredient - it’s verified. If nothing comes up, or if the details don’t match what’s on your bottle, stop using it.
For example, if you have a bottle of metformin with NDC 0078-0642-10, searching it shows it’s made by Mylan Pharmaceuticals, 500 mg tablets, approved since 2007. That’s solid. But if you search a number like 1234-5678-90 and get no results? That’s a red flag.
Who’s Making the Drug? Check the Manufacturer
Knowing the drug is approved isn’t enough. You also need to know who made it. The Drug Establishments Current Registration Site tells you which companies are legally registered to produce or distribute drugs in the U.S.
Let’s say your metformin says it’s made by "Global Pharma Corp." You can’t find that name in the NDC Directory. So you search the Drug Establishments site. If the company isn’t listed there, it’s not a registered U.S. drugmaker. That’s a major warning sign. Counterfeiters often use fake names that sound legit - like "MediCare USA" or "PharmaPlus Inc." - but they don’t exist in the FDA’s system.
Registered companies must renew their status every year between October 1 and December 31. If they don’t, they’re removed from the list. So if a company disappeared from the registry in 2023 but you’re seeing its name on a 2025 bottle? That’s not normal.
Spotting Counterfeit Drugs: The Red Flags
Counterfeit drugs look real. They have the right color, shape, and packaging. But they’re often made in unregulated labs - sometimes in China, India, or Eastern Europe - and shipped through shady online pharmacies. Here’s what to watch for:
- Misspellings on the label - "Metfomin" instead of "Metformin."
- Unusual packaging - different font, wrong logo size, missing batch numbers.
- Price too low - if a 30-day supply of a brand-name drug costs $5 online, it’s almost certainly fake.
- No prescription required - FDA-approved drugs in the U.S. require a prescription. Any site selling them without one is breaking the law.
- No NDC on the package - if there’s no NDC number at all, the drug isn’t legally distributed in the U.S.
The FDA estimates that 1 in 10 prescription drugs sold online are counterfeit. In 2022 alone, over 1,200 shipments of fake insulin, cancer meds, and heart drugs were intercepted at U.S. ports. Many of these drugs contain no active ingredient - or worse, toxic substances like rat poison, chalk, or industrial dyes.
The DSCSA System: What Changed in 2023
In November 2023, a major rule kicked in: the Drug Supply Chain Security Act (DSCSA). This didn’t just add paperwork - it changed how drugs are tracked from factory to pharmacy.
Before 2023, manufacturers just had to list their drugs in the NDC Directory. Now, every single package must have a unique identifier - a 2D barcode that includes the NDC, serial number, lot number, and expiration date. Pharmacies and distributors must scan these barcodes to verify each package before it’s sold.
This means if you get a drug from a U.S. pharmacy, it’s been scanned at least three times: when it left the factory, when it arrived at the distributor, and when it reached the pharmacy. If any step fails, the package is quarantined.
That’s why you might notice new labels on your medicine bottles now - tiny QR codes or barcodes that weren’t there before. That’s the DSCSA in action. It’s not perfect, but it’s the most advanced system of its kind in the world.
Why This Matters for You
You might think, "I buy from a local pharmacy. I’m safe." But even trusted pharmacies can get counterfeit drugs through third-party suppliers. In 2021, a major U.S. chain recalled 14,000 bottles of generic blood pressure medicine because they were traced back to a foreign supplier that didn’t follow DSCSA rules.
And what about online pharmacies? The FDA shut down over 10,000 illegal websites in 2023. Many of them look like real medical sites - they have professional designs, fake doctor testimonials, and even SSL certificates. But none of them are listed in the FDA’s Drug Establishments site. If you’re buying online, always check: Is the pharmacy licensed in your state? Does it have a physical address? And most importantly - can you verify the NDC number?
What the FDA Doesn’t Cover
There’s a big gap: compounded drugs. These are custom-made medications, often for allergies or rare conditions. They’re not subject to the same NDC rules. That means you can’t verify them using the FDA databases. If you’re taking compounded meds, ask your pharmacist: "Is this made by a licensed compounding pharmacy?" And check if they’re registered with your state’s board of pharmacy.
Also, supplements aren’t regulated the same way. The FDA doesn’t verify vitamins, herbs, or weight-loss pills like it does prescription drugs. So if you’re buying something labeled "natural" or "clinically proven," don’t assume it’s safe just because it’s sold in a pharmacy.
What to Do If You Find a Fake
If you suspect a drug is counterfeit:
- Stop taking it.
- Keep the packaging - including the bottle, box, and any inserts.
- Call your pharmacy and ask them to report it.
- Report it to the FDA at fda.gov/safety/medwatch.
Don’t wait. Fake drugs can cause organ damage, overdose, or even death. The FDA has a dedicated team that investigates these reports. In 2022, over 4,000 counterfeit drug reports were filed - and nearly 80% of them led to investigations.
Final Tip: Use the Orange Book Too
If you’re taking a generic drug, check the Orange Book - the FDA’s list of approved drug products with therapeutic equivalence ratings. This tells you if the generic you’re taking is truly equivalent to the brand-name version. Some generics look different and aren’t interchangeable. If your pharmacy switches your generic without telling you, use the Orange Book to confirm it’s still safe.
Can I trust online pharmacies that claim to be FDA-approved?
No. The FDA doesn’t approve online pharmacies. Only physical pharmacies licensed by state boards can be FDA-compliant. Any website claiming "FDA-approved" is lying. Always check if the site requires a prescription and if it lists a physical U.S. address and phone number. If it doesn’t, walk away.
What if my drug doesn’t have an NDC number?
If your medication has no NDC number on the packaging, it’s not legally distributed in the U.S. This applies to drugs bought online, imported from other countries, or sold in non-regulated markets. Never take a drug without a verifiable NDC. Contact your pharmacist or the FDA to report it.
Are all generics the same as brand-name drugs?
Most are, but not all. The FDA’s Orange Book rates generics as "AB" (therapeutically equivalent) or "BX" (not equivalent). If your generic is rated BX, it may not work the same way. Always check the Orange Book if you notice side effects after switching generics.
How do I know if a drug was recalled?
Search the NDC Directory. If a drug was recalled, its status changes to "inactive." You can also sign up for FDA recall alerts at fda.gov/safety/recalls. Recalls happen for contamination, mislabeling, or potency issues - not just counterfeits.
Do these databases work for international drugs?
Only if the drug is approved for sale in the U.S. The FDA databases only include drugs legally imported and sold here. Drugs bought from overseas pharmacies - even if they’re the same brand - may not be in the system. Importing prescription drugs from other countries is illegal in the U.S. unless under very limited exceptions.
Written by Connor Back
View all posts by: Connor Back