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
openFDA Listing Details
- Product ID
- 71335-1917_7da2dbe1-dd39-487c-99ee-59ff2fae4eb2
- SPL ID
- 7da2dbe1-dd39-487c-99ee-59ff2fae4eb2
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Sotalol Hydrochloride
- Generic name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2020-07-24
- Marketing category
- ANDA
- Application number
- ANDA075563
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA]; Antiarrhythmic [EPC]; Cardiac Rhythm Alteration [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| SOTALOL HYDROCHLORIDE | 80 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | HEC37C70XX |
| Rxcui | 1923426 |
| Spl Set Id | 2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1917-1 | 60 TABLET in 1 BOTTLE (71335-1917-1) | 2022-07-06 | No |
| 71335-1917-2 | 30 TABLET in 1 BOTTLE (71335-1917-2) | 2021-07-22 | No |
| 71335-1917-3 | 100 TABLET in 1 BOTTLE (71335-1917-3) | 2021-07-22 | No |
| 71335-1917-4 | 90 TABLET in 1 BOTTLE (71335-1917-4) | 2022-07-06 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| HEC37C70XX | SOTALOL HYDROCHLORIDE | 959-24-0 | SOTALOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1917-1 | 71335191701 | 60 TABLET in 1 BOTTLE (71335-1917-1) | 60 tablet | 2022-07-06 | No | No | Historical |
| 71335-1917-2 | 71335191702 | 30 TABLET in 1 BOTTLE (71335-1917-2) | 30 tablet | 2021-07-22 | No | No | Historical |
| 71335-1917-3 | 71335191703 | 100 TABLET in 1 BOTTLE (71335-1917-3) | 100 tablet | 2021-07-22 | No | No | Historical |
| 71335-1917-4 | 71335191704 | 90 TABLET in 1 BOTTLE (71335-1917-4) | 90 tablet | 2022-07-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sotalol Hydrochloride | Bryant Ranch Prepack | 2023-11-06 | HUMAN PRESCRIPTION DRUG LABEL | 103 |