FDA Databases: How to Verify Medications and Spot Counterfeit Drugs

Every year, millions of people in the U.S. take prescription meds without knowing if they’re real. Counterfeit drugs aren’t just a problem overseas-they’re hiding in plain sight. The FDA’s databases are the only trusted source to check if your medicine is legitimate. But most people don’t know how to use them. You don’t need to be a pharmacist to spot a fake. You just need to know where to look and what to look for.

What the FDA Databases Actually Do

The FDA doesn’t just approve drugs. It tracks every single prescription medication sold in the U.S. through three main systems: the NDC Directory, the Drug Establishments Current Registration Site, and the Electronic Drug Registration and Listing System (eDRLS). These aren’t just databases-they’re the backbone of drug safety in America.

The NDC Directory is the most important. Every approved drug gets a unique 10- or 11-digit National Drug Code. It’s split into three parts: the labeler (who makes it), the product (what it is), and the package (how it’s sold). If the NDC doesn’t exist in this directory, the drug isn’t legally approved. That’s your first red flag.

The Drug Establishments Current Registration Site tells you who’s allowed to make, pack, or distribute drugs. If a pharmacy or distributor isn’t listed here, they’re operating illegally. And eDRLS is where companies submit their drug info electronically. If a company hasn’t updated their listing in the last year, their drugs might not be tracked at all.

How Counterfeit Drugs Slip Through

Counterfeiters don’t break into labs. They exploit gaps in the system. Most fake drugs come from foreign suppliers who never registered with the FDA. They ship bulk powder or pills labeled with fake NDCs. These get mixed into legitimate supply chains through third-party distributors who skip verification.

Here’s how it works: A small pharmacy buys meds from an unregistered wholesaler. The wholesaler says the NDC is real. The pharmacy doesn’t check the FDA database. The pills get sold to you. By the time the FDA finds out, hundreds of people have taken them. In 2022, over 1,200 inspections found 68 companies with broken verification systems. That’s not a glitch-it’s a pattern.

Some fakes look perfect. The packaging matches. The pills have the right color and imprint. But the NDC won’t match. Or the manufacturer’s name won’t show up in the registration site. That’s why checking the database isn’t optional-it’s your last line of defense.

How to Check a Drug Yourself

You don’t need special tools. Just your phone and 2 minutes.

1. Find the NDC on the drug box. It’s usually printed near the barcode. Look for a 10- or 11-digit number, often with hyphens like 00012-3456-78.
2. Go to the FDA’s NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/
3. Enter the full NDC. Don’t guess. Don’t round. Type it exactly as it appears.
4. Check the results. If it shows the drug name, manufacturer, and active ingredient-you’re good.
5. If it says “Not Found,” “Inactive,” or “Unregistered”-stop. Don’t take it.

Now check the manufacturer. Go to the Drug Establishments Current Registration Site. Search by company name. If the company isn’t listed, the drug isn’t FDA-approved-even if the NDC looks real.

Pro tip: If you buy meds online, always verify the NDC before paying. A 2023 FDA report found that 63% of online pharmacies selling unapproved drugs had fake or invalid NDCs.

What the FDA Doesn’t Tell You

The system works-but only if everyone plays by the rules. The DSCSA law, fully in effect since November 2023, requires every company in the supply chain to electronically verify each drug package. But here’s the catch: the FDA doesn’t check every pill. They rely on companies to report problems.

Most small pharmacies and clinics still don’t have automated systems. They manually check NDCs. That’s slow. And mistakes happen. In 2021, 38% of verification failures were caused by mismatched NDC formats. One digit off, and the system rejects a real drug.

Also, the NDC doesn’t track individual pills. It tracks the product type. So if a box of 100 pills is fake, but the NDC is real, the system won’t flag it. That’s why the FDA is moving to a 12-digit NDC format by 2026-so each package gets a unique code, like a serial number.

Who’s Really Responsible?

You might think the FDA should stop all fakes. But they can’t. They inspect 1,200 companies a year. There are over 18,000 registered drug establishments. They rely on you to report suspicious meds.

If you find a drug that looks wrong-wrong color, wrong shape, weird taste, or no NDC-report it. Use the FDA’s MedWatch system. It’s free. It’s anonymous. And it helps them shut down bad actors.

Pharmacies and hospitals are required to report suspect drugs within 24 hours. But most patients don’t know they can do the same. Your report could save someone’s life.

What’s Changing in 2026

The FDA is upgrading the NDC system to 12 digits, adding images of pills to the database, and integrating AI tools to spot fake patterns. By 2026, you’ll be able to scan a pill’s barcode and see its real-time history-where it was made, who shipped it, and if it’s been flagged.

Right now, companies like TraceLink and SAP help big pharma track drugs. But soon, the FDA will give patients access to the same data. That means your phone could tell you if the bottle you bought was shipped from a verified warehouse-or a warehouse in a country with no FDA oversight.

Until then, the simplest tool you have is the NDC Directory. Use it every time you get a new prescription. Especially if you’re buying online, from a foreign pharmacy, or from a discount site that seems too good to be true.

Real-World Example: A Patient’s Close Call

In 2022, a woman in Ohio bought generic metformin from a website offering 80% off. The pills looked normal. The bottle had a label. But when she checked the NDC, it didn’t exist in the FDA database. She called her pharmacist. They confirmed it was fake. The pills had no active ingredient. She could’ve had a diabetic emergency.

She reported it. The FDA traced it to a lab in India. The website was shut down. Ten other patients were found to have taken the same fake batch. None were hospitalized. But it was close.

That’s the difference between checking and assuming.

What to Do If You Find a Fake

• Stop taking the medication.
• Keep the packaging and pills as evidence.
• Report it to the FDA at MedWatch.
• Call your pharmacy. Ask if they’ve seen similar reports.
• If you’re on a chronic drug, contact your doctor immediately. Don’t go without treatment.

Don’t wait for symptoms. Fake drugs don’t always make you sick right away. Sometimes, they just don’t work. And that’s just as dangerous.

Final Advice: Don’t Guess, Check

Counterfeit drugs aren’t rare. They’re everywhere. And the people selling them know you won’t check. That’s why they win.

You don’t need to be a scientist to protect yourself. You just need to know where to look. The FDA’s databases are free. They’re public. And they’re designed for people like you-not just pharmacists or regulators.

Next time you pick up a new prescription, take 90 seconds to verify the NDC. It’s the simplest, most effective way to make sure your medicine is real. And in a world where fake drugs can kill, that’s not just smart-it’s essential.