Sotalol Hydrochloride

Product NDC
71610-849
11-digit product format
716100849
Labeler code
71610
Product ID
71610-849_1f2ee516-a618-876f-e063-6394a90a3114
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076140
Marketing category
ANDA
Marketing start
2003-02-01
Substance
SOTALOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
HEC37C70XXSOTALOL HYDROCHLORIDE959-24-0SOTALOL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-849-8071610084980180 TABLET in 1 BOTTLE (71610-849-80) 180 tablet2024-08-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sotalol HydrochlorideAphena Pharma Solutions - Tennessee, LLC2024-08-08HUMAN PRESCRIPTION DRUG LABEL1