alosetron hydrochloride

Generic: alosetron hydrochloride

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

Drug Facts

Product Profile

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

alosetron hydrochloride .5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-248
Product ID 53746-248_acd7e4c4-f9c9-4dae-b42e-e25622de9921
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206647
Listing Expiration 2026-12-31
Marketing Start 2023-09-06

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 53746248
Hyphenated Format 53746-248

Supplemental Identifiers

RxCUI
259306 403975
UPC
0353746249302 0353746248305
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
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (53746-248-30)
source: ndc

Packages (1)

53746-248-30 30 TABLET, FILM COATED in 1 BOTTLE (53746-248-30)

Ingredients (1)

alosetron hydrochloride (.5 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": "acd7e4c4-f9c9-4dae-b42e-e25622de9921", "openfda": {"upc": ["0353746249302", "0353746248305"], "unii": ["2F5R1A46YW"], "rxcui": ["259306", "403975"], "spl_set_id": ["2927e7d0-b1b8-4944-a7e8-97b60eb9bb71"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (53746-248-30)", "package_ndc": "53746-248-30", "marketing_start_date": "20230906"}], "brand_name": "Alosetron Hydrochloride", "product_id": "53746-248_acd7e4c4-f9c9-4dae-b42e-e25622de9921", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "53746-248", "generic_name": "Alosetron Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alosetron Hydrochloride", "active_ingredients": [{"name": "ALOSETRON HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA206647", "marketing_category": "ANDA", "marketing_start_date": "20230906", "listing_expiration_date": "20261231"}