Sotalol Hydrochloride
- Product NDC
- 69584-843
- 11-digit product format
- 695840843
- Labeler code
- 69584
- Product ID
- 69584-843_71c67f34-73e1-4e4c-9c72-56f4b9222a88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Oxford Pharmaceuticals, LLC
- Application
- ANDA075563
- Marketing category
- ANDA
- Marketing start
- 2020-07-24
- 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 | 904589, 1923422, 1923424, 1923426 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69584-843-10 | Sotalol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69584-843 | SOTALOL HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231111_c8ac6351-b1e9-4dd2-82f2-5980814fda15.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 |
|---|
| 69584-843-10 | 69584084310 | 100 TABLET in 1 BOTTLE (69584-843-10) | 100 tablet | 2020-07-24 | 0000-00-00 | No | No | Current |