Alosetron Hydrochloride

Orange BookUNIISPLATC A03AE01

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeA03AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7319003530
30 TABLET, FILM COATED in 1 BOTTLE (73190-035-30)

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": "73190-035_3e64c1e9-713c-8f82-e063-6394a90a7bbb",
  "productndc": "73190-035",
  "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": "20250725",
  "active_numerator_strength": ".5"
}

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