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Metformin hydrochloride

NDC 76385-128 · UNICHEM PHARMACEUTICALS (USA), INC.

Generic nameMetformin hydrochloride
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
Active ingredient(s)METFORMIN HYDROCHLORIDE
Strength500 mg/1
Pharmacologic classBiguanide [EPC], Biguanides [CS]
Marketing categoryANDA

Packages

76385-128-01 — 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-01)

76385-128-10 — 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-10)

76385-128-50 — 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

72789-400 — metformin hydrochloride, 72789-409 — metformin hydrochloride, 72789-451 — Metformin Hydrochloride, 72789-454 — Metformin Hydrochloride, 72789-455 — metformin hydrochloride, 72789-472 — Metformin Hydrochloride, 72789-531 — Metformin HCl, 72789-548 — Metformin Hydrochloride, 72789-551 — METFORMIN HYDROCHLORIDE, 72789-561 — METFORMIN HYDROCHLORIDE, 76385-129 — Metformin hydrochloride, 80425-0435 — Metformin HCl, 80425-0591 — metformin hydrochloride, 82009-046 — Metformin Hydrochloride Tablet, 82009-047 — Metformin Hydrochloride Tablet, 82009-117 — Metformin ER 500 mg, 82009-118 — Metformin ER 750 mg, 82009-174 — METFORMIN HYDROCHLORIDE, 82009-175 — METFORMIN HYDROCHLORIDE, 82009-180 — Metformin Hydrochloride, +600 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels