Nifedipine
Nifedipine Capsule, USP Rx only
Approved
Approval ID
5014847e-389d-48c1-8350-b9b24ca8d2a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-739
Application NumberANDA202644
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2023
FDA Product Classification
INGREDIENTS (16)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
NIFEDIPINEActive
Quantity: 10 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
Nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-740
Application NumberANDA202644
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2023
FDA Product Classification
INGREDIENTS (19)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
NIFEDIPINEActive
Quantity: 20 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT