Alosetron Hydrochloride
- Product NDC
- 0054-0296
- 11-digit product format
- 000540296
- Labeler code
- 0054
- Product ID
- 0054-0296_ca09da58-08c8-4520-b2a7-f33d3feaa15f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alosetron hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA200652
- Marketing category
- ANDA
- Marketing start
- 2013-07-15
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0054-0296 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0054-0296 | 0054-0296-13 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0054-0296 | 0054-0296-25 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A200652-001 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | | | 2015-05-04 |
| A200652-002 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | | | 2015-05-04 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALOSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | 2F5R1A46YW | ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 1 | |
| ALOSETRON | ACTIVE MOIETY | 13Z9HTH115 | ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] | 1 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0296-13 | 00054029613 | 30 TABLET in 1 BOTTLE (0054-0296-13) | 30 tablet | 2015-05-04 | 0000-00-00 | No | No | Current |
| 0054-0296-25 | 00054029625 | 100 TABLET in 1 BOTTLE (0054-0296-25) | 100 tablet | 2015-05-04 | 0000-00-00 | No | No | Current |