Metformin HCl

Product NDC
72789-531
11-digit product format
727890531
Labeler code
72789
Product ID
72789-531_40c15fb3-40a5-08ec-e063-6294a90aec7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090564
Marketing category
ANDA
Marketing start
2017-02-06
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 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
72789-531-427278905314242 TABLET in 1 BOTTLE, PLASTIC (72789-531-42) 42 tablet2025-10-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metformin Hydrochloride Tablets USPPD-Rx Pharmaceuticals, Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL2