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United States · US · US:53746-249_acd7e4c4-f9c9-4dae-b42e-e25622de9921
Alosetron Hydrochloride
Orange BookUNIISPLATC A03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeA03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11537462493030 TABLET, FILM COATED in 1 BOTTLE (53746-249-30)
Annotations
UNII (FDA Substance ID)
2F5R1A46YW
ALOSETRON HYDROCHLORIDE
RxCUI 85247
Orange Book
A206647
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": {
"38f5341f-5ae3-46bf-8bfc-30dff2068477": {
"match": "brand_token",
"title": "ALOSETRON TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-04-03"
}
},
"productid": "53746-249_acd7e4c4-f9c9-4dae-b42e-e25622de9921",
"productndc": "53746-249",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206647",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Dec 22, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Dec 22, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALOSETRON HYDROCHLORIDE",
"proprietary_name": "Alosetron Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206647",
"marketing_category": "ANDA",
"nonproprietary_name": "Alosetron Hydrochloride",
"start_marketing_date": "20230906",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A03AE01.
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