Nifedipine
Nifedipine Extended-release Tablets, USP
Approved
Approval ID
331db003-cc8e-4509-9415-20e48c5cc5b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 30, 2023
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 006422406
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62175-260
Application NumberANDA077127
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification
INGREDIENTS (17)
NIFEDIPINEActive
Quantity: 30 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62175-261
Application NumberANDA077127
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification
INGREDIENTS (17)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
NIFEDIPINEActive
Quantity: 60 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62175-262
Application NumberANDA077127
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification
INGREDIENTS (17)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
NIFEDIPINEActive
Quantity: 90 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT