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Metformin Hydrochloride

NDC 0378-6001 · Mylan Pharmaceuticals Inc.

Generic namemetformin
Dosage formTABLET, FILM COATED, EXTENDED RELEASE
RouteORAL
Active ingredient(s)METFORMIN HYDROCHLORIDE
Strength1000 mg/1
Pharmacologic classBiguanide [EPC], Biguanides [CS]
Marketing categoryANDA

Packages

0378-6001-91 — 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0006-5373 — ertugliflozin and metformin hydrochloride, 0006-5374 — ertugliflozin and metformin hydrochloride, 0093-7455 — Glipizide and Metformin Hydrochloride, 0093-7456 — Glipizide and Metformin Hydrochloride, 0093-7457 — Glipizide and Metformin Hydrochloride, 0310-6225 — dapagliflozin and metformin hydrochloride, 0310-6250 — dapagliflozin and metformin hydrochloride, 0310-6260 — dapagliflozin and metformin hydrochloride, 0310-6270 — dapagliflozin and metformin hydrochloride, 0310-6280 — dapagliflozin and metformin hydrochloride, 0378-6002 — metformin, 0378-7185 — metformin hydrochloride, 0378-7186 — metformin hydrochloride, 0378-7187 — metformin hydrochloride, 0378-8175 — saxagliptin and metformin, 0378-8176 — saxagliptin and metformin, 0378-8177 — saxagliptin and metformin, 0597-0146 — linagliptin and metformin hydrochloride, 0597-0147 — linagliptin and metformin hydrochloride, 0597-0148 — linagliptin and 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