Alosetron Hydrochloride
- Product NDC
- 53746-248
- 11-digit product format
- 537460248
- Labeler code
- 53746
- Product ID
- 53746-248_acd7e4c4-f9c9-4dae-b42e-e25622de9921
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alosetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA206647
- Marketing category
- ANDA
- Marketing start
- 2023-09-06
- Substance
- ALOSETRON HYDROCHLORIDE
- Active strength
- .5 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alosetron Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALOSETRON HYDROCHLORIDE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2F5R1A46YW |
| Rxcui | 259306, 403975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-248-30 | Alosetron Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-248 | ALOSETRON HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 1 | Current NDC, 1 package rows | 20231027_2927e7d0-b1b8-4944-a7e8-97b60eb9bb71.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-248-30 | 53746024830 | 30 TABLET, FILM COATED in 1 BOTTLE (53746-248-30) | 2023-09-06 | No | No | Historical |