Sotalol Hydrochloride
- Product NDC
- 55154-8179
- 11-digit product format
- 551548179
- Labeler code
- 55154
- Product ID
- 55154-8179_860b7d5f-efce-45a9-91d9-273d318ed5c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA076140
- Marketing category
- ANDA
- Marketing start
- 2014-03-11
- 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 |
|---|
| 55154-8179-0 | Sotalol Hydrochloride | 10 in 1 BAG | TABLET | 10 | | 6 |
| 55154-8179-0 | Sotalol Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-8179 | SOTALOL HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240627_4f5902e1-9f9f-4c6b-817d-2efbb5e28061.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-8179-0 | 55154817900 | 10 BLISTER PACK in 1 BAG (55154-8179-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2014-03-11 | 0000-00-00 | No | No | Current |