alosetron hydrochloride
- Product NDC
- 64980-453
- 11-digit product format
- 649800453
- Labeler code
- 64980
- Product ID
- 64980-453_485cb247-48d8-4bc3-b16b-a0abadea856b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alosetron hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA209180
- Marketing category
- ANDA
- Marketing start
- 2019-01-14
- 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 | 64980-453 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 64980-453 | 64980-453-03 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 64980-453 | 64980-453-50 | 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 |
|---|
| A209180-001 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | | 2019-01-14 |
| A209180-002 | ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | | 2019-01-14 |
Therapeutic equivalence codes#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64980-453-03 | 64980045303 | 30 TABLET in 1 BOTTLE (64980-453-03) | 30 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 64980-453-50 | 64980045350 | 500 TABLET in 1 BOTTLE (64980-453-50) | 500 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |