Approved medicine

What does approval tell me?

Start with the product, its form and the use on its label. A drug name alone leaves gaps.

Term in plain words

FDA approval

Approval means the Food and Drug Administration (FDA) has reviewed a particular medicine’s evidence and accepted it for a named use.

Check these points

  • Match the name and the form

    Semaglutide is the ingredient in Ozempic and Wegovy. Both brands have approved shots and tablets in the US, as of September 26, 2026. Approved Ozempic uses include type 2 diabetes; approved Wegovy uses include weight management.

    Ask whether you are being offered a shot or a tablet. Write the ingredient’s name beside the brand name, the name on the package.

  • Ask what the label covers

    The ingredient used in Mounjaro and Zepbound injections is tirzepatide. As of September 26, 2026, approved uses include type 2 diabetes for Mounjaro and weight management for Zepbound.

    Those are examples of approved uses. Ask to see the full approved label and which use applies to your problem.

  • Ask about a proposed change

    If the offer switches from an approved product to a pharmacy-made version, ask why.

    As of September 26, 2026, a compounded preparation does not share an approved product’s FDA approval.

Notes that explain the checks

What “off-label” means

“Off-label” means using an approved medicine for a reason outside the uses on its approved label. Ask whether studies show it helps your problem.

Keep that question separate from whether the product itself has approval.

A medicine number is not proof of approval

The FDA’s drug list uses a medicine identification number called a National Drug Code, or NDC. As of September 26, 2026, the FDA says having this number does not prove approval.

If an offer shows an NDC number, ask for the FDA page showing approval of the exact product and its approved label. Match the ingredient, brand and shot or tablet to the offer.

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