Sotalol
- Product NDC
- 10135-661
- 11-digit product format
- 101350661
- Labeler code
- 10135
- Product ID
- 10135-661_d21adcb6-0083-7e25-e053-2a95a90a406d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA207428
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- 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 |
|---|
| 10135-661-01 | Sotalol | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 4 |
| 10135-661-50 | Sotalol | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-661 | SOTALOL (SOTALOL HYDROCHLORIDE) TABLET [MARLEX PHARMACEUTICALS INC] | 4 | Legacy NDC, 2 package rows | 20211202_3c24cdf0-4648-4e5d-993c-1f428ce56a65.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 |
|---|
| 10135-661-01 | 10135066101 | 100 TABLET in 1 BOTTLE, PLASTIC (10135-661-01) | 100 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 10135-661-50 | 10135066150 | 500 TABLET in 1 BOTTLE, PLASTIC (10135-661-50) | 500 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |