Sotalol

Basic Information

Product Name

Sotalol

FDA Product Code

71610-385

Regulatory Information

NDC Product Code

71610-385

Application Number

ANDA207428

Marketing Category

C73584

Effective Date

January 22, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS. SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SOTALOL HYDROCHLORIDE

Quantity: 80 mg in 1 1

Code: HEC37C70XX

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

Code: A6D97U294I

Sotalol

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

CELLULOSE, MICROCRYSTALLINE

FD&C BLUE NO. 2

STARCH, CORN

SILICON DIOXIDE

STEARIC ACID

MAGNESIUM STEARATE

Active Moieties

SOTALOL