Carvedilol

Basic Information

Product Name

Carvedilol

FDA Product Code

63629-4060

Regulatory Information

NDC Product Code

63629-4060

Application Number

ANDA077614

Marketing Category

C73584

Effective Date

November 8, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use.Initial U.S. Approval: 1995

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CARVEDILOL

Quantity: 3.125 mg in 1 1

Code: 0K47UL67F2

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CROSPOVIDONE (35 .MU.M)

Code: 40UAA97IT9

Class Code: IACT

Active Moieties

Code: 0K47UL67F2

Carvedilol

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

HYPROMELLOSE, UNSPECIFIED

MAGNESIUM STEARATE

POVIDONE K30

SILICON DIOXIDE

TALC

POLYETHYLENE GLYCOL, UNSPECIFIED

TITANIUM DIOXIDE

CROSPOVIDONE (35 .MU.M)

Active Moieties

CARVEDILOL