nifedipine
Nifedipine Extended-Release Tablets, USP For Oral Use
Approved
Approval ID
1df07edb-630d-4c70-a68c-bdbc607ce850
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Elite Pharmaceutical Solution, Inc.
DUNS: 073650048
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 Code70807-503
Application NumberANDA212016
Product Classification
M
Marketing Category
C73584
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2021
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
NIFEDIPINEActive
Quantity: 90 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT