Metformin HCl

Product NDC
70518-4479
11-digit product format
705184479
Labeler code
70518
Product ID
70518-4479_3ed5e404-5a23-701f-e063-6394a90a7b09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090564
Marketing category
ANDA
Marketing start
2025-09-13
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
786Z46389EMETFORMIN HYDROCHLORIDE1115-70-4METFORMIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4479-07051844790090 TABLET in 1 BOTTLE, PLASTIC (70518-4479-0) 90 tablet2025-09-13NoNoHistorical
70518-4479-170518447901100 TABLET in 1 BOTTLE, PLASTIC (70518-4479-1) 100 tablet2025-09-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metformin Hydrochloride Tablets USPREMEDYREPACK INC.2025-09-15HUMAN PRESCRIPTION DRUG LABEL1