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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1326
Application NumberANDA072579
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2012
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1521
Application NumberANDA072579
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2012
FDA Product Classification
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