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FDA Product

Carvedilol Phosphate

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

Basic Information

Carvedilol Phosphate

63629-9635

Regulatory Information

63629-9635

ANDA090132

C73584

February 19, 2021

USA

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

HUMAN PRESCRIPTION DRUG LABEL

100

Company Information

171714327

Active Ingredients

CARVEDILOL PHOSPHATE

Quantity: 80 mg in 1 1

Code: EQT531S367

Class Code: ACTIB

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Code: NX76LV5T8J

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

Active Moieties

CARVEDILOL

Code: 0K47UL67F2

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