METFORMIN HYDROCHLORIDE

Product NDC
62207-497
11-digit product format
622070497
Labeler code
62207
Product ID
62207-497_414662c8-b86d-4c80-e063-6294a90a3cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA213344
Marketing category
ANDA
Marketing start
2021-02-01
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 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
62207-497-4762207049747500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-497-47) 2021-02-01NoNoHistorical
62207-497-546220704975430 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-497-54) 2021-02-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METFORMIN HYDROCHLORIDEGranules India Ltd2025-10-16HUMAN PRESCRIPTION DRUG LABEL6
METFORMIN HYDROCHLORIDEGranules India Ltd2023-01-27HUMAN PRESCRIPTION DRUG LABEL5