NIFEDIPINE
Approved
Approval ID
0d592c37-b38c-4fb6-a1d3-96531384ae8d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
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 Code16590-319
Application NumberANDA072579
Product Classification
M
Marketing Category
C73584
G
Generic Name
NIFEDIPINE
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2011
FDA Product Classification
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NIFEDIPINEActive
Quantity: 10 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT