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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

d3625d78-6eb6-41fe-8f6f-664965c104c4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

Manufacturers
FDA

Waylis Therapeutics LLC

DUNS: 117678921

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80725-388
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
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
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 Code80725-383
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification

INGREDIENTS (6)

carvedilol phosphateActive
Quantity: 10 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 Code80725-387
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification

INGREDIENTS (6)

CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
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

Carvedilol Phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80725-385
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
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
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

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