LOTRONEX
- Product NDC
- 54766-894
- 11-digit product format
- 547660894
- Labeler code
- 54766
- Product ID
- 54766-894_87fd4e30-01d6-6ab3-e053-2995a90a522f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alosetron hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Application
- NDA021107
- Marketing category
- NDA
- Marketing start
- 2016-07-11
- Marketing end
- 0000-00-00
- Substance
- ALOSETRON HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-894 | LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [SEBELA PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20190507_35cbb9d5-639b-207a-e054-00144ff88e88.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54766-894-03 | 54766089403 | 30 TABLET in 1 BOTTLE (54766-894-03) | 30 tablet | 2016-07-11 | 0000-00-00 | No | No | Current |