Alosetron Hydrochloride
- Product NDC
- 45963-479
- 11-digit product format
- 459630479
- Labeler code
- 45963
- Product ID
- 45963-479_963590cd-862a-cf1d-e053-2a95a90af4c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alosetron hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021107
- Marketing category
- NDA
- Marketing start
- 2015-05-26
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| alosetron hydrochloride | ACTIVE INGREDIENT | 2F5R1A46YW | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| alosetron | ACTIVE MOIETY | 13Z9HTH115 | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| indigotindisulfonate sodium | INACTIVE INGREDIENT | D3741U8K7L | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-479 | ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] | 11 | Legacy NDC | 20241215_969429cb-60b9-4a9c-be60-dd01994431b2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-479-03 | 45963047903 | 1 BOTTLE in 1 CARTON (45963-479-03) > 30 TABLET in 1 BOTTLE | 1 bottle | 2015-05-26 | 0000-00-00 | No | No | Current |