Sotalol Hydrochloride
- Product NDC
- 0904-7143
- 11-digit product format
- 009047143
- Labeler code
- 0904
- Product ID
- 0904-7143_2b64f084-8d8f-454c-834b-16e8d1439c77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076140
- Marketing category
- ANDA
- Marketing start
- 2003-02-01
- 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 |
|---|
| 0904-7143-61 | Sotalol Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 0904-7143-61 | Sotalol Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7143 | SOTALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240802_866e5717-3de2-4f19-b7c7-2275caeef78b.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 |
|---|
| 0904-7143-61 | 00904714361 | 100 BLISTER PACK in 1 CARTON (0904-7143-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2003-02-01 | 0000-00-00 | No | No | Current |