lotronex

Generic: alosetron hydrochloride

Labeler: sebela pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lotronex
Generic Name alosetron hydrochloride
Labeler sebela pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alosetron hydrochloride 1 mg/1

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-895
Product ID 54766-895_43143464-47b5-0b88-e063-6394a90a01ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021107
Marketing Start 2016-07-11
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 54766895
Hyphenated Format 54766-895

Supplemental Identifiers

RxCUI
259306 261362 403975 540181
UPC
0354766894039 0354766895036
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 lotronex (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
  • 30 TABLET in 1 BOTTLE (54766-895-03)
source: ndc

Packages (1)

54766-895-03 30 TABLET in 1 BOTTLE (54766-895-03)

Ingredients (1)

alosetron hydrochloride (1 mg/1)

Linked Drug Pages (1)

LOTRONEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43143464-47b5-0b88-e063-6394a90a01ef", "openfda": {"upc": ["0354766894039", "0354766895036"], "unii": ["2F5R1A46YW"], "rxcui": ["259306", "261362", "403975", "540181"], "spl_set_id": ["35cbb9d5-639b-207a-e054-00144ff88e88"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (54766-895-03)", "package_ndc": "54766-895-03", "marketing_end_date": "20260430", "marketing_start_date": "20160711"}], "brand_name": "LOTRONEX", "product_id": "54766-895_43143464-47b5-0b88-e063-6394a90a01ef", "dosage_form": "TABLET", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "54766-895", "generic_name": "alosetron hydrochloride", "labeler_name": "Sebela Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOTRONEX", "active_ingredients": [{"name": "ALOSETRON HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "NDA021107", "marketing_category": "NDA", "marketing_end_date": "20260430", "marketing_start_date": "20160711"}