Sotalol Hydrochloride

Product NDC
71610-723
11-digit product format
716100723
Labeler code
71610
Product ID
71610-723_15689e23-7236-4cfd-8ab4-9b8450b82299
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
2002-09-26
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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-723-307161007233030 TABLET in 1 BOTTLE (71610-723-30) 30 tablet2023-08-07NoNoHistorical
71610-723-607161007236090 TABLET in 1 BOTTLE (71610-723-60) 90 tablet2023-08-07NoNoHistorical
71610-723-8071610072380180 TABLET in 1 BOTTLE (71610-723-80) 180 tablet2023-08-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sotalol HydrochlorideAphena Pharma Solutions - Tennessee, LLC2023-08-08HUMAN PRESCRIPTION DRUG LABEL2