How to Search FDA’s Drugs@FDA Database for Official Drug Information

Need to find out when a drug was approved by the FDA? Or want to see the full prescribing label, review documents, or approval letters? You don’t need to call the agency or file a Freedom of Information Act request. The Drugs@FDA database gives you all that - for free, right from your browser.

Launched in the early 2000s and updated daily since, Drugs@FDA is the U.S. Food and Drug Administration’s official public record of approved human drugs. It includes information on over 20,000 medications, from common prescriptions like metformin and lisinopril to newer biologics and specialty drugs. The database covers products approved as far back as 1939, though detailed documents like full labels and review summaries are available for most drugs approved after 1998.

What You Can Find in Drugs@FDA

When you search for a drug in Drugs@FDA, you’re not just getting a list of brand names. You’re accessing the full regulatory history. For each drug, you can typically find:

• Brand names and generic names
• Active ingredients and dosage forms (tablet, injection, etc.)
• Approval date and application number (NDA, ANDA, or BLA)
• Full prescribing information (label) in PDF format
• Patient Medication Guides
• Review documents from FDA medical officers
• Approval letters and correspondence with the manufacturer

This isn’t marketing material. These are official FDA documents - the same ones regulators used to make approval decisions. That’s why pharmacists, doctors, researchers, and even patients use it to verify drug status, check for generic equivalents, or understand why a drug was approved or restricted.

How to Search Drugs@FDA: Three Ways That Work

The search interface is simple, but if you use the wrong method, you might miss key results. There are three main ways to search, and each has different strengths.

1. Use the Main Search Box (Recommended)

On the Drugs@FDA homepage, the big search bar at the top is your best tool. Type in:

• A brand name: Zestril
• A generic name: lisinopril
• An active ingredient: hydrochlorothiazide
• An application number: NDA 020386

It doesn’t matter if you use uppercase or lowercase. The system is smart enough to match variations. If you search for lisinopril, you’ll see all products containing it - including combination drugs like Zestoretic (lisinopril + hydrochlorothiazide) and all brand names like Prinivil, Zestril, and QBrelis.

This is the only search method that returns full results for combination products and all brand names tied to an ingredient. If you’re looking for every version of a drug, this is your go-to.

2. Use the A-Z Index (Use With Caution)

Under the search box, you’ll see a link to “A-Z Index.” It looks helpful - but it’s misleading. This index only searches by established name (generic name) and doesn’t include brand names or combination products.

For example, if you search for LISINOPRIL in the A-Z index, you’ll only see the generic version. You won’t see Zestril, Prinivil, or Zestoretic. That’s a major limitation. Most users don’t realize this until they’re frustrated by missing results.

Only use the A-Z index if you’re specifically looking for the generic version of a drug and know exactly what you’re after. Otherwise, skip it and use the main search box.

3. Search by Application Number

If you already know the NDA, ANDA, or BLA number (often found on FDA press releases or in regulatory filings), you can enter it directly into the search box. This is the fastest way to pull up the exact drug record you need - especially useful for researchers, attorneys, or industry professionals.

Application numbers follow a pattern:

• NDA: New Drug Application (brand-name drugs)
• ANDA: Abbreviated New Drug Application (generic drugs)
• BLA: Biologics License Application (vaccines, monoclonal antibodies, etc.)

Example: NDA 020386 is Zestril (lisinopril). Type that number in, and you’ll jump straight to the full approval package.

Understanding the Results Page

After you search, you’ll see a list of matching drugs. Each entry shows:

• Brand name (if any)
• Generic name
• Active ingredient(s)
• Dosage form and strength
• Applicant name (the company that submitted the application)
• Approval date
• Application number

Click on any drug to open its full record. Here’s where the real value is.

Inside the drug record, you’ll see tabs:

• Products - lists all versions of the drug (different strengths, formulations)
• Active Ingredients - shows all active components
• Applications - links to the original application documents
• Labeling - the full prescribing information, updated to the latest version
• Review Documents - FDA’s internal medical and pharmacology reviews
• Correspondence - letters between FDA and the company

Download the label PDF to see the full boxed warning, dosage instructions, drug interactions, and contraindications. These are the same documents doctors use to make prescribing decisions.

What Drugs@FDA Doesn’t Cover

Even though it’s powerful, Drugs@FDA isn’t the only FDA database. Here’s what it leaves out:

• Patent and exclusivity info - That’s the Orange Book. If you need to know when a generic can launch or if a drug has market exclusivity, check the Electronic Orange Book.
• Deep labeling searches - If you want to find every drug with a specific boxed warning or adverse reaction listed, use FDALabel. It lets you search by section, which Drugs@FDA doesn’t.
• Biologics only - The Purple Book covers biological products like Humira, Keytruda, and insulin biosimilars. Drugs@FDA includes biologics too, but the Purple Book is more detailed for these.
• Animal drugs - If you’re looking for veterinary medications, use Animal Drugs@FDA.

Think of Drugs@FDA as your starting point. It gives you the big picture: when the drug was approved, who made it, and what the FDA said about it. Then use other databases if you need deeper details.

Why Healthcare Professionals Rely on It

Pharmacists use Drugs@FDA daily to answer patient questions: “Is this generic the same as my brand?” “When was this drug first approved?” “Why did my insurance deny it?”

Doctors use it to verify off-label use history or check if a drug has been withdrawn or restricted. Researchers use it to track approval trends or build datasets for studies. Patients use it to understand what they’re taking - without relying on pharmaceutical ads or third-party websites that might be outdated.

One pharmacist told the FDA: “I used to call the agency every week. Now I just pull up Drugs@FDA. It saves me hours.”

Pro Tips for Better Searches

• Always start with the main search box. Don’t waste time with the A-Z index unless you’re certain you only need the generic name.
• Try spelling variations. If “metoprolol” doesn’t work, try “metoprolol tartrate” or “metoprolol succinate.”
• Use the application number if you have it - it’s the most precise way to find a drug.
• Download and save labels. If you find a useful prescribing guide, download the PDF. It won’t change, and you’ll have it offline.
• Check the approval date. Drugs approved before 1998 may have limited documentation. If you need more, you might need to request records through the FDA’s public reading room.

Final Thoughts

Drugs@FDA isn’t flashy. It doesn’t have fancy filters or AI suggestions. But it’s the most reliable source for FDA-approved drug information you’ll ever find. No paywalls. No ads. No guesswork.

If you’re a healthcare worker, a student, a researcher, or just someone who wants to know what’s in the medicine you’re taking - this is your database. Master the main search box, ignore the A-Z trap, and you’ll have direct access to the FDA’s decision-making records - exactly as they were written.

It’s not just information. It’s transparency - built into the system so you don’t have to ask for it.