Sotalol Hydrochloride
- Product NDC
- 71610-474
- 11-digit product format
- 716100474
- Labeler code
- 71610
- Product ID
- 71610-474_c2c1a3a6-f70e-4b47-85b6-e4d10c110588
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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 |
|---|
| 71610-474-60 | 71610047460 | 90 TABLET in 1 BOTTLE (71610-474-60) | 90 tablet | 2022-01-25 | No | No | Historical |
| 71610-474-80 | 71610047480 | 180 TABLET in 1 BOTTLE (71610-474-80) | 180 tablet | 2020-10-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sotalol Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | 2022-02-22 | HUMAN PRESCRIPTION DRUG LABEL | 2 |