Sotalol
- Product NDC
- 71335-1189
- 11-digit product format
- 713351189
- Labeler code
- 71335
- Product ID
- 71335-1189_ca49d506-4490-469e-8084-b687dd488a88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207428
- Marketing category
- ANDA
- Marketing start
- 2017-12-15
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOTALOL HYDROCHLORIDE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HEC37C70XX |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1189-1 | 2024-05-20 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-1 | 2024-05-20 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-2 | 2024-05-20 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-2 | 2024-05-20 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-3 | 2024-05-20 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-3 | 2024-05-20 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
| 71335-1189-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5dba-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1189-1 | Sotalol | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 71335-1189-2 | Sotalol | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 71335-1189-3 | Sotalol | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 71335-1189-4 | Sotalol | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1189 | SOTALOL (SOTALOL HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240522_c824f6b2-80c5-45a6-a491-4c14c9f5e33d.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 |
|---|
| 71335-1189-1 | 71335118901 | 60 TABLET in 1 BOTTLE (71335-1189-1) | 60 tablet | 2019-04-15 | 0000-00-00 | No | No | Current |
| 71335-1189-2 | 71335118902 | 30 TABLET in 1 BOTTLE (71335-1189-2) | 30 tablet | 2019-04-22 | 0000-00-00 | No | No | Current |
| 71335-1189-3 | 71335118903 | 100 TABLET in 1 BOTTLE (71335-1189-3) | 100 tablet | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1189-4 | 71335118904 | 90 TABLET in 1 BOTTLE (71335-1189-4) | 90 tablet | 2024-05-17 | | No | No | Current |