CARVEDILOL

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

RedPharm Drug, Inc.

DUNS Number

828374897

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

67296-1497

Application Number

ANDA078165

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 2, 2023

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive

Code: T4V6TWG28DClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 800Inactive

Code: UH6KR4953DClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Code: 0K47UL67F2Class: ACTIBQuantity: 12.5 mg in 1 1