Track metformin in Peptimes
Metformin is a biguanide. FDA-approved products contain it as metformin hydrochloride and are taken by mouth as tablets, extended-release tablets or an oral solution. (Source: DailyMed label.)
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.
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.
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