Nifedipine
Nifedipine Capsules
Approved
Approval ID
ce3366e2-ede3-4321-bd1c-8aacc869fe46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2009
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-2870
Application NumberANDA072781
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2009
FDA Product Classification
INGREDIENTS (13)
NIFEDIPINEActive
Quantity: 10 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT