SOTALOL HYDROCHLORIDE
- Product NDC
- 59651-777
- 11-digit product format
- 596510777
- Labeler code
- 59651
- Product ID
- 59651-777_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
- 160 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 | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HEC37C70XX |
| Rxcui | 1922720, 1922763, 1922765 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-777-01 | SOTALOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-777 | SOTALOL HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 1 package rows | 20241004_6f3145d7-f3c9-4456-a77d-d04c54f24668.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-777-01 | 59651077701 | 100 TABLET in 1 BOTTLE (59651-777-01) | 100 tablet | 2023-06-29 | No | No | Current |