COREG
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) extended-release capsules for oral use Initial U.S. Approval: 1995
Approved
Approval ID
06400a4c-42b4-440a-92b4-1f47f98ac7ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2020
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3373
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CARVEDILOL PHOSPHATEActive
Quantity: 80 mg in 1 1
Code: EQT531S367
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3387
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CARVEDILOL PHOSPHATEActive
Quantity: 40 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
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
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3388
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CARVEDILOL PHOSPHATEActive
Quantity: 80 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3370
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CARVEDILOL PHOSPHATEActive
Quantity: 10 mg in 1 1
Code: EQT531S367
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3371
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CARVEDILOL PHOSPHATEActive
Quantity: 20 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3372
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CARVEDILOL PHOSPHATEActive
Quantity: 40 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
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
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3385
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CARVEDILOL PHOSPHATEActive
Quantity: 20 mg in 1 1
Code: EQT531S367
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carvedilol phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0007-3383
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2020
FDA Product Classification
INGREDIENTS (6)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CARVEDILOL PHOSPHATEActive
Quantity: 10 mg in 1 1
Code: EQT531S367
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT