SOTALOL HYDROCHLORIDE
- Product NDC
- 11788-054
- 11-digit product format
- 117880054
- Labeler code
- 11788
- Product ID
- 11788-054_d2c31b08-0c64-48be-aa84-aeaead306b2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOTALOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA075500
- Marketing category
- ANDA
- Marketing start
- 2025-11-01
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 240 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 | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HEC37C70XX |
| Rxcui | 904589, 1923422, 1923424, 1923426 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11788-054-01 | SOTALOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 11788-054-01 | 11788005401 | 100 TABLET in 1 BOTTLE (11788-054-01) | 100 tablet | 2025-11-01 | No | No | Historical |