Alosetron

Orange BookUNIISPLATC A03AE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeA03AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362925181
30 TABLET in 1 BOTTLE (63629-2518-1)

Annotations

UNII (FDA Substance ID)

2F5R1A46YW

ALOSETRON HYDROCHLORIDE

RxCUI 85247

Orange Book

A213614

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": "63629-2518_cd337c95-1e5a-4dfa-84f7-e668c93d8565",
  "productndc": "63629-2518",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213614",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Sep 9, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALOSETRON HYDROCHLORIDE",
  "proprietary_name": "Alosetron",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213614",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alosetron",
  "start_marketing_date": "20200914",
  "active_numerator_strength": "1"
}

Related drugs

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