Sotalol Hydrochloride
- Product NDC
- 71335-2823
- 11-digit product format
- 713352823
- Labeler code
- 71335
- Product ID
- 71335-2823_8aaf8e38-d3f0-4ba6-8168-21b978532601
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075563
- Marketing category
- ANDA
- Marketing start
- 2020-07-24
- 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| HEC37C70XX | SOTALOL HYDROCHLORIDE | 959-24-0 | SOTALOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2823-1 | 71335282301 | 100 TABLET in 1 BOTTLE (71335-2823-1) | 100 tablet | 2025-11-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sotalol Hydrochloride | Bryant Ranch Prepack | 2025-11-10 | HUMAN PRESCRIPTION DRUG LABEL | 100 |