Sotalol Hydrochloride
- Product NDC
- 50090-7796
- 11-digit product format
- 500907796
- Labeler code
- 50090
- Product ID
- 50090-7796_4d187dd3-c6fd-4e9a-a56a-b42b9f1d8882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sotalol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOTALOL HYDROCHLORIDE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HEC37C70XX |
| Rxcui | 1923426 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7796-0 | Sotalol Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 50090-7796-2 | Sotalol Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7796-0 | 50090779600 | 60 TABLET in 1 BOTTLE (50090-7796-0) | 60 tablet | 2025-11-25 | No | No | Historical |
| 50090-7796-2 | 50090779602 | 90 TABLET in 1 BOTTLE (50090-7796-2) | 90 tablet | 2025-12-03 | No | No | Historical |