Sotalol Hydrochloride
- Product NDC
- 76385-125
- 11-digit product format
- 763850125
- Labeler code
- 76385
- Product ID
- 76385-125_fe9ac463-547d-4917-a98e-61f1c0fe38f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride Tables AF
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- UNICHEM PHARMACEUTICALS (USA), INC.
- Application
- ANDA207429
- Marketing category
- ANDA
- Marketing start
- 2020-02-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sotalol Hydrochloride
- Brand name suffix
- AF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SOTALOL HYDROCHLORIDE | 80 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | HEC37C70XX |
| Rxcui | 1922720, 1922763, 1922765, 1923422, 1923424, 1923426 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 83083289-08f8-450a-8eff-9d912bdd64bb | Product name | 1 | 20200505 |
| 8b3790df-333b-074c-6570-5beaa3352b77 | Product name | 2 | 20190213 |
| 424d69b0-0855-4fff-846d-7ced5f554385 | Product name | 1 | 20150403 |
| 9ab69b37-6a2f-6dca-a9fd-3131946f16f2 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76385-125-01 | Sotalol HydrochlorideAF | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 5 | |
| 76385-125-50 | Sotalol HydrochlorideAF | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 5 | |
| 76385-125-01 | Sotalol HydrochlorideAF | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 2 | |
| 76385-125-50 | Sotalol HydrochlorideAF | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76385-125-01 | EA - Each | 76385-125 | ff427051-984f-4c73-85ce-918bd9460682 | 1 | 2020-03-10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76385-125 | SOTALOL HYDROCHLORIDE AF (SOTALOL HYDROCHLORIDE TABLES AF) TABLET SOTALOL HYDROCHLORIDE AF (SOTALOL HYDROCHLORIDE TABLETS AF) TABLET [BAYSHORE PHARMACEUTICALS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240118_2577dd8d-ab1b-4a55-990a-18c69395edfe.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1923422 | sotalol HCl 120 MG Oral Tablet | PSN | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1923424 | sotalol HCl 160 MG Oral Tablet | PSN | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1923426 | sotalol HCl 80 MG Oral Tablet | PSN | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922720 | sotalol HCl AF 120 MG Oral Tablet | PSN | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922763 | sotalol HCl AF 160 MG Oral Tablet | PSN | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922765 | sotalol HCl AF 80 MG Oral Tablet | PSN | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922720 | Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet | SCD | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922763 | Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet | SCD | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922765 | Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet | SCD | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1923422 | sotalol hydrochloride 120 MG Oral Tablet | SCD | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1923424 | sotalol hydrochloride 160 MG Oral Tablet | SCD | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1923426 | sotalol hydrochloride 80 MG Oral Tablet | SCD | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922763 | sotalol HCl AF 160 MG Oral Tablet | SY | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922765 | sotalol HCl AF 80 MG Oral Tablet | SY | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922720 | sotalol hydrochloride AF 120 MG Oral Tablet | SY | 56879738-8662-4f5c-8386-761ab2b5e46f | 5 |
| 1922720 | sotalol HCl AF 120 MG Oral Tablet | PSN | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922763 | sotalol HCl AF 160 MG Oral Tablet | PSN | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922765 | sotalol HCl AF 80 MG Oral Tablet | PSN | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922720 | Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet | SCD | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922763 | Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet | SCD | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922765 | Atrial Fibrillation sotalol hydrochloride 80 MG Oral Tablet | SCD | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922763 | sotalol HCl AF 160 MG Oral Tablet | SY | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922765 | sotalol HCl AF 80 MG Oral Tablet | SY | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
| 1922720 | sotalol hydrochloride AF 120 MG Oral Tablet | SY | 2577dd8d-ab1b-4a55-990a-18c69395edfe | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76385-125-01 | 76385012501 | 100 TABLET in 1 BOTTLE, PLASTIC (76385-125-01) | 100 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 76385-125-50 | 76385012550 | 500 TABLET in 1 BOTTLE, PLASTIC (76385-125-50) | 500 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |