Sotalol Hydrochloride
- Product NDC
- 51655-450
- 11-digit product format
- 516550450
- Labeler code
- 51655
- Product ID
- 51655-450_490ece67-ce5a-8020-e063-6394a90a9bac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA076140
- Marketing category
- ANDA
- Marketing start
- 2023-06-14
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sotalol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOTALOL HYDROCHLORIDE | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HEC37C70XX |
| Rxcui | 904589 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-450-15 | Sotalol Hydrochloride | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-450 | SOTALOL HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20240723_fe82c866-03d4-e07b-e053-6394a90a8b1e.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 |
|---|
| 51655-450-15 | 51655045015 | 50 TABLET in 1 BOTTLE, PLASTIC (51655-450-15) | 50 tablet | 2023-06-14 | No | No | Current |