SOTALOL HYDROCHLORIDE
- Product NDC
- 72162-2583
- 11-digit product format
- 721622583
- Labeler code
- 72162
- Product ID
- 72162-2583_99d9a66c-6522-4d66-a6c7-f83d9c4e68ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOTALOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075500
- Marketing category
- ANDA
- Marketing start
- 2025-11-01
- 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 |
|---|
| 72162-2583-1 | SOTALOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2583-1 | 72162258301 | 100 TABLET in 1 BOTTLE (72162-2583-1) | 100 tablet | 2025-11-24 | No | No | Historical |