alosetron hydrochloride

Generic: alosetron hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name alosetron hydrochloride
Generic Name alosetron hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alosetron hydrochloride 1 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-480
Product ID 45963-480_29143d6e-9e10-cd2f-e063-6394a90a2e07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021107
Marketing Start 2015-05-26
Marketing End 2026-04-30

Pharmacologic Class

Classes
serotonin 3 receptor antagonists [moa] serotonin-3 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963480
Hyphenated Format 45963-480

Supplemental Identifiers

RxCUI
259306 403975
UPC
0345963479037 0345963480033
UNII
2F5R1A46YW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alosetron hydrochloride (source: ndc)
Generic Name alosetron hydrochloride (source: ndc)
Application Number NDA021107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

45963-480-03 1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE

Ingredients (1)

alosetron hydrochloride (1 mg/1)

Linked Drug Pages (1)

Alosetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29143d6e-9e10-cd2f-e063-6394a90a2e07", "openfda": {"upc": ["0345963479037", "0345963480033"], "unii": ["2F5R1A46YW"], "rxcui": ["259306", "403975"], "spl_set_id": ["969429cb-60b9-4a9c-be60-dd01994431b2"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45963-480-03)  / 30 TABLET in 1 BOTTLE", "package_ndc": "45963-480-03", "marketing_end_date": "20260430", "marketing_start_date": "20150526"}], "brand_name": "Alosetron Hydrochloride", "product_id": "45963-480_29143d6e-9e10-cd2f-e063-6394a90a2e07", "dosage_form": "TABLET", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "45963-480", "generic_name": "alosetron hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alosetron Hydrochloride", "active_ingredients": [{"name": "ALOSETRON HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "NDA021107", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260430", "marketing_start_date": "20150526"}