Sotalol Hydrochloride
- Product NDC
- 10135-715
- 11-digit product format
- 101350715
- Labeler code
- 10135
- Product ID
- 10135-715_b945b073-8372-826c-e053-2995a90ad9b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA207429
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- Marketing end
- 0000-00-00
- Substance
- SOTALOL HYDROCHLORIDE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-715-01 | Sotalol HydrochlorideAF | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-715 | SOTALOL HYDROCHLORIDE AF (SOTALOL HYDROCHLORIDE) TABLET [MARLEX PHARMACEUTICALS INC] | 4 | Legacy NDC, 1 package rows | 20210120_7c9cc47c-1cb2-405d-8c8a-50226482ede2.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 |
|---|
| 10135-715-01 | 10135071501 | 100 TABLET in 1 BOTTLE, PLASTIC (10135-715-01) | 100 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |