MedPath
FDA Product

Coreg CR

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Coreg CR

69784-388

Regulatory Information

69784-388

NDA022012

C73594

February 28, 2022

USA

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

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

080406260

Active Ingredients

carvedilol phosphate

Quantity: 80 mg in 1 1

Code: EQT531S367

Class Code: ACTIB

Inactive Ingredients

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

HYDROGENATED CASTOR OIL

Code: ZF94AP8MEY

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

Active Moieties

CARVEDILOL

Code: 0K47UL67F2

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