CARVEDILOL

Basic Information

Product Name

CARVEDILOL

FDA Product Code

70518-3524

Regulatory Information

NDC Product Code

70518-3524

Application Number

ANDA078165

Marketing Category

C73584

Effective Date

March 21, 2024

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

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYETHYL CELLULOSE, UNSPECIFIED

Code: T4V6TWG28D

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POLYETHYLENE GLYCOL 800

Code: UH6KR4953D

Class Code: IACT

CARVEDILOL

Quantity: 6.25 mg in 1 1

Code: 0K47UL67F2

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

Active Moieties

Code: 0K47UL67F2

CARVEDILOL

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

HYDROXYETHYL CELLULOSE, UNSPECIFIED

CROSCARMELLOSE SODIUM

POLYETHYLENE GLYCOL 800

TITANIUM DIOXIDE

MICROCRYSTALLINE CELLULOSE

ANHYDROUS LACTOSE

Active Moieties

CARVEDILOL