alosetron hydrochloride

Generic: alosetron hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alosetron hydrochloride
Generic Name alosetron hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

alosetron hydrochloride 1 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-249
Product ID 65162-249_c13f2cbc-86c6-4f24-8933-7219f6aa34bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206647
Listing Expiration 2026-12-31
Marketing Start 2017-01-02

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 65162249
Hyphenated Format 65162-249

Supplemental Identifiers

RxCUI
259306 403975
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 ANDA206647 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65162-249-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65162-249-50)
source: ndc

Packages (2)

65162-249-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-249-03) 65162-249-50 500 TABLET, FILM COATED in 1 BOTTLE (65162-249-50)

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": "c13f2cbc-86c6-4f24-8933-7219f6aa34bd", "openfda": {"unii": ["2F5R1A46YW"], "rxcui": ["259306", "403975"], "spl_set_id": ["ba94ab71-11d7-4ce1-9b21-0b8c6a39e993"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-249-03)", "package_ndc": "65162-249-03", "marketing_start_date": "20170102"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65162-249-50)", "package_ndc": "65162-249-50", "marketing_start_date": "20170102"}], "brand_name": "Alosetron Hydrochloride", "product_id": "65162-249_c13f2cbc-86c6-4f24-8933-7219f6aa34bd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "65162-249", "generic_name": "Alosetron Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alosetron Hydrochloride", "active_ingredients": [{"name": "ALOSETRON HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA206647", "marketing_category": "ANDA", "marketing_start_date": "20170102", "listing_expiration_date": "20261231"}