METFORMIN HYDROCHLORIDE
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
d320647a-6feb-55e8-e053-2a95a90a362a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METFORMIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2595
Application NumberANDA203769
Product Classification
M
Marketing Category
C73584
G
Generic Name
METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2021
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 850 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT