Carvedilol Phosphate
These highlights do not include all the information needed to use Carvedilol Phosphate extended-release capsules safely and effectively. See full prescribing information for Carvedilol Phosphate extended-release capsules. Carvedilol Phosphate extended-release capsules for oral use Initial U.S. Approval: 1995
Approved
Approval ID
e434f355-6f29-4a98-9702-9fc65de2aa26
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2022
Manufacturers
FDA
Woodward Pharma Services LLC
DUNS: 080406260
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-714
Application NumberNDA022012
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 1, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carvedilol phosphateActive
Quantity: 20 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-716
Application NumberNDA022012
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 1, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
carvedilol phosphateActive
Quantity: 80 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-713
Application NumberNDA022012
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 1, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
carvedilol phosphateActive
Quantity: 10 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-715
Application NumberNDA022012
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 1, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
carvedilol phosphateActive
Quantity: 40 mg in 1 1
Code: EQT531S367
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT