FDA Databases: How to Verify Medications and Avoid Counterfeit Drugs

Every year, millions of people in the U.S. take prescription drugs without ever checking if they’re real. That’s a dangerous habit. Counterfeit medications aren’t just fake-they can be laced with rat poison, chalk, or nothing at all. And while most drugs come from legitimate sources, the FDA estimates that counterfeit drugs cost the global pharmaceutical industry over $200 billion annually. The good news? You don’t need to be a pharmacist to spot them. The FDA has built public databases that let anyone check if a drug is approved, properly labeled, and legally sold in the U.S.

What the FDA Databases Actually Do

The FDA doesn’t just approve drugs. It tracks them from the factory to your pharmacy. Three main databases work together to make this possible: the NDC Directory, the Drug Establishments Current Registration Site, and the Orange Book. These aren’t hidden systems. They’re free, public, and updated daily.

The NDC Directory is your first stop. Every approved drug in the U.S. gets a National Drug Code-a 10- or 11-digit number that breaks down into three parts: the labeler (who makes it), the product (what it is), and the package (how it’s sold). If a drug doesn’t have a valid NDC in this database, it’s not legally approved. That includes many online pills sold as "generic" versions of popular drugs. If you see a pill with no NDC on the box, walk away.

The Drug Establishments Current Registration Site tells you who’s allowed to make or distribute drugs. Every company that handles prescription meds must register with the FDA and renew every year. If a pharmacy or distributor isn’t listed here, they’re operating illegally. You can search by company name or location. No listing? That’s a red flag.

The Orange Book lists drugs approved as therapeutically equivalent. That means if your doctor prescribes a brand-name drug, you can safely switch to a generic listed here. But if a generic isn’t in the Orange Book, it might not work the same-or worse, it might be fake.

How to Use the NDC Directory to Check a Drug

Let’s say you bought a bottle of metformin online. The label says it’s made by "Global Pharma LLC." You’re not sure. Here’s how to check:

1. Find the NDC on the package. It’s usually printed near the barcode. Example: 0002-0402-01
2. Go to the FDA’s NDC Directory at fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
3. Enter the full NDC number into the search box.
4. Check the results: Is the labeler name the same? Is the drug approved for the same use? Is the packaging size correct?

If the search returns nothing, the drug isn’t FDA-approved. If the labeler name doesn’t match, it’s likely counterfeit. If the dosage is wrong or the form (tablet vs. capsule) doesn’t match, it’s a red flag.

Pro tip: Don’t rely on the label alone. Fake packages look real. The NDC is the only guaranteed identifier. Even if the bottle says "FDA-approved," if it’s not in the database, it’s a lie.

Spotting Fake Drugs: Real-World Red Flags

Counterfeiters don’t just copy the pill. They copy the whole box. But they miss details. Here’s what to look for:

• Spelling errors on the label
• Unusual pill color, size, or imprint
• Missing or blurry barcodes
• Price that’s too good to be true (e.g., 90% off brand-name insulin)
• Online sellers without a physical address or phone number
• Pharmacies that don’t require a prescription

In 2022, the FDA seized over 10 million counterfeit pills-many of them fake versions of opioids, diabetes meds, and heart drugs. One batch of fake metformin contained boric acid. Another had no active ingredient at all. Patients didn’t know until they had a medical emergency.

The most dangerous counterfeits are those that look perfect. That’s why checking the NDC is non-negotiable. A 2021 FDA study found that 87% of counterfeit drugs passed visual inspection by pharmacists. Only the database caught them.

What the DSCSA Changes Mean for You

Starting November 27, 2023, the Drug Supply Chain Security Act (DSCSA) made a big shift. Before, companies only had to verify drugs at the batch level. Now, every single package must have a unique identifier-like a serial number on a phone.

This means pharmacies and distributors must scan each pill bottle before selling it. If the code doesn’t match the manufacturer’s system, the drug is quarantined. This system is still rolling out, but it’s already cutting counterfeit incidents by 78% in companies that use it fully.

For you, the consumer, this means fewer fake drugs will reach shelves. But it doesn’t mean you can relax. The system only works if everyone plays by the rules. Foreign suppliers? Only 35% comply. Online pharmacies? Many still operate outside the system.

Why You Can’t Rely on Google or Amazon

You might think, "I’ll just Google the drug name and see what comes up." Don’t. Amazon, eBay, and social media sellers often list fake drugs with fake FDA claims. The FDA doesn’t regulate online pharmacies unless they’re registered with them. And most aren’t.

There are only 3,000 verified online pharmacies in the U.S. Out of over 35,000 websites selling drugs, 96% are illegal. The FDA’s website has a list of verified pharmacies you can trust. If a site isn’t on that list, assume it’s unsafe.

What to Do If You Find a Fake Drug

If you suspect a drug is counterfeit:

1. Stop taking it.
2. Keep the packaging and any receipts.
3. Report it to the FDA’s MedWatch program at fda.gov/medwatch.
4. Call your pharmacist or doctor.

The FDA gets over 1,000 reports of suspected counterfeit drugs every year. Most come from patients. Your report helps them shut down dangerous operations.

Who’s Responsible for This System?

The FDA doesn’t do this alone. Manufacturers, distributors, and pharmacies all have legal obligations under DSCSA. They must:

• Register with the FDA annually
• Submit accurate drug listings in electronic format
• Verify every drug they handle
• Keep records for six years

Companies that fail face fines, shutdowns, or criminal charges. In 2022, the FDA issued 68 warning letters for DSCSA violations. That’s not a slap on the wrist-it’s a legal threat.

But the system isn’t perfect. A 2022 survey found that 38% of verification failures happened because different companies used different NDC formats. One company might list a drug as 0002-0402-01, another as 00002-0402-01. The FDA is fixing this by moving to a 12-digit NDC format by 2026.

Bottom Line: Don’t Guess. Check.

You don’t need to understand all the tech behind FDA databases. You just need to know this: if you’re taking a prescription drug, check its NDC. It takes 30 seconds. It could save your life.

Counterfeit drugs aren’t a distant threat. They’re in your medicine cabinet right now-if you haven’t checked. The FDA built these tools so you don’t have to trust a label, a website, or a salesperson. You can trust data. Use it.