Sotalol Hydrochloride
- Product NDC
- 43353-616
- 11-digit product format
- 433530616
- Labeler code
- 43353
- Product ID
- 43353-616_c68dff8e-c8ac-4ed4-8700-a70b920554a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075563
- Marketing category
- ANDA
- Marketing start
- 2003-11-07
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-616 | SOTALOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20171127_28ba5f2a-ed6b-49a7-8a11-2d811ce9d946.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-616-30 | 43353061630 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-616-30) | 30 tablet | 2010-03-10 | 0000-00-00 | No | No | Current |
| 43353-616-60 | 43353061660 | 90 TABLET in 1 BOTTLE, PLASTIC (43353-616-60) | 90 tablet | 2010-03-10 | 0000-00-00 | No | No | Current |