Nifedipine
Nifedipine Extended-Release Tablets For Oral Use
Approved
Approval ID
adaa3246-d0fc-417c-9a16-81d76f153903
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
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 Code53808-0389
Application NumberANDA077899
Product Classification
M
Marketing Category
C73584
G
Generic Name
NIFEDIPINE
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (10)
NIFEDIPINEActive
Quantity: 30 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NIFEDIPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0387
Application NumberANDA077899
Product Classification
M
Marketing Category
C73584
G
Generic Name
NIFEDIPINE
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
NIFEDIPINEActive
Quantity: 60 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT