Is metformin FDA-approved?

Yes, as specific products: generic metformin tablets, extended-release tablets and oral solution are FDA-approved for the uses in their labels, and they're prescription only. The brands are listed as discontinued.

Checked 25 Oct 2026. The sources are below.

Metformin

Also: metformin hydrochloride, 1,1-dimethylbiguanide, Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Generic metformin hydrochloride tablets, extended-release tablets and oral solution, from several manufacturers

    Oral

    As stated on each product's label (approved through abbreviated new drug applications, ANDAs): glycemic control with diet and exercise in type 2 diabetes mellitus, in the patients each label defines. The brands are listed as discontinued.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each marketed metformin product as "Prescription".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add metformin in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the entry above gives the products it applies to.

  • Logging: the amount you took and how you feel.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell metformin or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 020357 (Glucophage) and NDA 021202 (Glucophage XR), checked 25 Oct 2026: both listed as discontinued, like the other metformin brands; generic tablets, extended-release tablets and oral solution are listed under “Metformin hydrochloride”.
  • National Library of Medicine, DailyMed, metformin hydrochloride tablets label, one generic’s label, checked 25 Oct 2026: section 1 and section 11 (description).
  • FDA, Global Substance Registration System, Metformin, checked 25 Oct 2026: the name 1,1-dimethylbiguanide.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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