Sotalol Hydrochloride
- Product NDC
- 71335-1917
- 11-digit product format
- 713351917
- Labeler code
- 71335
- Product ID
- 71335-1917_7da2dbe1-dd39-487c-99ee-59ff2fae4eb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075563
- Marketing category
- ANDA
- Marketing start
- 2020-07-24
- 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 |
|---|
| 71335-1917-1 | Sotalol Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 103 |
| 71335-1917-2 | Sotalol Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 103 |
| 71335-1917-3 | Sotalol Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 103 |
| 71335-1917-4 | Sotalol Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1917 | SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 4 package rows | 20231108_2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0.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 |
|---|
| 71335-1917-1 | 71335191701 | 60 TABLET in 1 BOTTLE (71335-1917-1) | 60 tablet | 2022-07-06 | 0000-00-00 | No | No | Current |
| 71335-1917-2 | 71335191702 | 30 TABLET in 1 BOTTLE (71335-1917-2) | 30 tablet | 2021-07-22 | 0000-00-00 | No | No | Current |
| 71335-1917-3 | 71335191703 | 100 TABLET in 1 BOTTLE (71335-1917-3) | 100 tablet | 2021-07-22 | 0000-00-00 | No | No | Current |
| 71335-1917-4 | 71335191704 | 90 TABLET in 1 BOTTLE (71335-1917-4) | 90 tablet | 2022-07-06 | 0000-00-00 | No | No | Current |