Nifedipine
Approved
Approval ID
093a8712-c860-4524-86f6-a9edcd35b882
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nifedipine
PRODUCT DETAILS
NDC Product Code43353-929
Application NumberANDA201071
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 23, 2014
Generic Namenifedipine
INGREDIENTS (10)
NIFEDIPINEActive
Quantity: 30 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT