Procardia
PROCARDIA XL (nifedipine) Extended Release Tablets For Oral Use
Approved
Approval ID
8ebcb33c-f43b-4b36-9f94-9774b2a59e06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 3
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 Code0069-2650
Application NumberNDA019684
Product Classification
M
Marketing Category
C73594
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (9)
NIFEDIPINEActive
Quantity: 30 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-2660
Application NumberNDA019684
Product Classification
M
Marketing Category
C73594
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (9)
NIFEDIPINEActive
Quantity: 60 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-2670
Application NumberNDA019684
Product Classification
M
Marketing Category
C73594
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (9)
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
NIFEDIPINEActive
Quantity: 90 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 11/27/2023
LAB-0176-13.0
Revised November 2023