Coreg CR
These highlights do not include all the information needed to use COREG CR safely and effectively. See full prescribing information for COREG CR. COREG CR (carvedilol phosphate) for oral use Initial U.S. Approval: 1995
Approved
Approval ID
9008ede8-3e53-4061-ae4c-c51cbbb56ef2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 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 Code69784-383
Application NumberNDA022012
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 28, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carvedilol phosphateActive
Quantity: 10 mg in 1 1
Code: EQT531S367
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-385
Application NumberNDA022012
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 28, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-388
Application NumberNDA022012
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 28, 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: 80 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
Carvedilol Phosphate
PRODUCT DETAILS
NDC Product Code69784-387
Application NumberNDA022012
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 28, 2022
Generic NameCarvedilol Phosphate
INGREDIENTS (6)
carvedilol phosphateActive
Quantity: 40 mg in 1 1
Code: EQT531S367
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT