METFORMIN HYDROCHLORIDE

Product NDC
68071-3739
11-digit product format
680713739
Labeler code
68071
Product ID
68071-3739_289dca09-c957-304e-e063-6394a90a5ca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA213320
Marketing category
ANDA
Marketing start
2023-01-19
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
68071-3739-168071373901100 TABLET in 1 BOTTLE (68071-3739-1) 100 tablet2024-12-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.2024-12-06HUMAN PRESCRIPTION DRUG LABEL1