Alosetron Hydrochloride
- Product NDC
- 65162-248
- 11-digit product format
- 651620248
- Labeler code
- 65162
- Product ID
- 65162-248_c13f2cbc-86c6-4f24-8933-7219f6aa34bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alosetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA206647
- Marketing category
- ANDA
- Marketing start
- 2017-01-02
- 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 |
|---|
| 65162-248-03 | Alosetron Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 18 |
| 65162-248-50 | Alosetron Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-248 | ALOSETRON HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241025_ba94ab71-11d7-4ce1-9b21-0b8c6a39e993.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-248-03 | 65162024803 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-248-03) | 2017-01-02 | 0000-00-00 | No | No | Current |
| 65162-248-50 | 65162024850 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-248-50) | 2017-01-02 | 0000-00-00 | No | No | Current |