LOTRONEX
- Product NDC
- 65483-894
- 11-digit product format
- 654830894
- Labeler code
- 65483
- Product ID
- 65483-894_800b0802-c4e6-409f-adbc-a985d1fca2a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alosetron hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Prometheus Laboratories Inc.
- Application
- NDA021107
- Marketing category
- NDA
- Marketing start
- 2009-02-09
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| 9a726e57-9bfe-419e-b2fb-835ed905be3d | Product name | 6 | 20210511 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65483-894-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8095-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LOTRONEX safely and effectively. See full prescribing information for LOTRONEX. LOTRONEX (alosetron hydrochloride) Tablets Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65483-894-03 | LOTRONEX | 30 in 1 BOTTLE | TABLET | 30 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65483-894-03 | EA - Each | 65483-894 | d732c59c-6de4-4f35-8596-441fbc579fe6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403975 | alosetron HCl 0.5 MG Oral Tablet | PSN | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 259306 | alosetron HCl 1 MG Oral Tablet | PSN | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 540181 | Lotronex 0.5 MG Oral Tablet | PSN | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 261362 | Lotronex 1 MG Oral Tablet | PSN | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 540181 | alosetron 0.5 MG Oral Tablet [Lotronex] | SBD | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 261362 | alosetron 1 MG Oral Tablet [Lotronex] | SBD | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 403975 | alosetron 0.5 MG Oral Tablet | SCD | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 259306 | alosetron 1 MG Oral Tablet | SCD | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 403975 | alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral Tablet | SY | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 259306 | alosetron 1 MG (as alosetron HCl 1.124 MG) Oral Tablet | SY | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 540181 | Lotronex 0.5 MG (alosetron hydrochloride 0.562 MG) Oral Tablet | SY | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 540181 | Lotronex 0.5 MG Oral Tablet | SY | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 261362 | Lotronex 1 MG (alosetron hydrochloride 1.124 MG) Oral Tablet | SY | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
| 261362 | Lotronex 1 MG Oral Tablet | SY | 526ba44c-a476-4675-a63c-4d0a72b723f5 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 65483-894-03 | 65483089403 | 30 in 1 BOTTLE | Historical |