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United States · US · US:83107-012_4db1d464-27cc-80a9-e063-6394a90ade00
LOTRONEX
Orange BookUNIISPLATC A03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLegacy Pharma USA Inc.
CountryUS (United States)
ATC codeA03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11831070123030 TABLET in 1 BOTTLE (83107-012-30)
Annotations
UNII (FDA Substance ID)
2F5R1A46YW
ALOSETRON HYDROCHLORIDE
RxCUI 85247
Orange Book
N021107
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2F5R1A46YW",
"rxcui": "85247",
"inchikey": "FNYQZOVOVDSGJH-UHFFFAOYSA-N",
"display_name": "ALOSETRON HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c216e967-436f-475a-8e6a-2ad11adc63af": {
"match": "brand_token",
"title": "LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [LEGACY PHARMA USA INC.]",
"spl_version": "2",
"published_date": "2026-03-24"
}
},
"productid": "83107-012_4db1d464-27cc-80a9-e063-6394a90ade00",
"productndc": "83107-012",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021107",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Feb 9, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "002",
"approval_date": "Dec 23, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALOSETRON HYDROCHLORIDE",
"proprietary_name": "LOTRONEX",
"active_ingred_unit": "mg/1",
"application_number": "NDA021107",
"marketing_category": "NDA",
"nonproprietary_name": "alosetron hydrochloride",
"start_marketing_date": "20260101",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A03AE01.
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