SOTALOL HYDROCHLORIDE
- Product NDC
- 59651-776
- 11-digit product format
- 596510776
- Labeler code
- 59651
- Product ID
- 59651-776_8a142042-e510-4232-8f20-5c92a991bd91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOTALOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077616
- Marketing category
- ANDA
- Marketing start
- 2023-06-29
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 120 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 |
|---|
| 59651-776-01 | 59651077601 | 100 TABLET in 1 BOTTLE (59651-776-01) | 100 tablet | 2023-06-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SOTALOL HYDROCHLORIDE | Aurobindo Pharma Limited | 2024-10-03 | Human Prescription Drug Label | 2 |