Metformin

Product NDC
50090-6516
11-digit product format
500906516
Labeler code
50090
Product ID
50090-6516_6f6a733e-a4a7-4578-bdea-cbf28f860765
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin ER 500 mg
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209313
Marketing category
ANDA
Marketing start
2018-07-31
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-6516-05009065160090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6516-0) 2023-06-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mgA-S Medication Solutions2025-01-09HUMAN PRESCRIPTION DRUG LABEL4