Metformin Hydrochloride
These highlights do not include all the information needed to use metformin hydrochloride extended-release tablets safely and effectively. See full prescribing information for metformin hydrochloride extended-release tablets. Metformin hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
96c8a89d-99db-24b1-e053-2a95a90ac2b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2022
Manufacturers
FDA
AiPing Pharmaceutical, Inc.
DUNS: 079674526
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin Hydrochloride Extended-Release Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11788-038
Application NumberANDA209993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride Extended-Release Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2022
FDA Product Classification
INGREDIENTS (14)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Metformin Hydrochloride Extended-Release Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11788-037
Application NumberANDA209993
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metformin Hydrochloride Extended-Release Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2022
FDA Product Classification
INGREDIENTS (14)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB