Sotalol Hydrochloride
- Product NDC
- 0378-5123
- 11-digit product format
- 003785123
- Labeler code
- 0378
- Product ID
- 0378-5123_3f4eac4d-6f01-4e6a-8144-65448519efdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sotalol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA077616
- Marketing category
- ANDA
- Marketing start
- 2007-02-20
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5123-01 | 00378512301 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-5123-01) | 100 tablet | 2007-02-20 | 0000-00-00 | No | No | Current |