Nifedipine
40-8986 Revised — November 2008
Approved
Approval ID
5733e038-7cb5-434b-aa8e-abb25e6252c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nifedipine
PRODUCT DETAILS
NDC Product Code54868-1326
Application NumberANDA072579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 26, 2012
Generic NameNifedipine
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
NIFEDIPINEActive
Quantity: 10 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Nifedipine
PRODUCT DETAILS
NDC Product Code54868-1521
Application NumberANDA072579
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 26, 2012
Generic NameNifedipine
INGREDIENTS (12)
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
NIFEDIPINEActive
Quantity: 20 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT