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FDA Drug information

Carvedilol

Read time: 1 mins
Marketing start date: 26 Mar 2023

Summary of product characteristics


Effective Time

20221031

Version

7

Spl Product Data Elements

Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND Z;1 Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SILICON DIOXIDE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND ZC40 Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 TALC TITANIUM DIOXIDE SILICON DIOXIDE WHITE TO OFF-WHITE ROUND ZC41 Carvedilol Carvedilol CARVEDILOL CARVEDILOL CROSPOVIDONE (12 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 TALC TITANIUM DIOXIDE SILICON DIOXIDE WHITE TO OFF-WHITE ROUND ZC42

Application Number

ANDA077614

Brand Name

Carvedilol

Generic Name

Carvedilol

Product Ndc

65841-619

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-616-01 in bottle of 100 Tablets Carvedilol Tablets USP, 3.125 mg R x only 100 Tablets NDC 65841-617-01 in bottle of 100 Tablets Carvedilol Tablets USP, 6.25 mg R x only 100 Tablets NDC 65841-618-01 in bottle of 100 Tablets Carvedilol Tablets USP, 12.5 mg R x only 100 Tablets NDC 65841-619-01 in bottle of 100 Tablets Carvedilol Tablets USP, 25 mg R x only 100 Tablets Carvedilol Tablets, 3.125 mg Carvedilol Tablets, 6.25 mg Carvedilol Tablets, 12.5 mg Carvedilol Tablets,25 mg

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