palonosetron hydrochloride

{
  "unii": {
    "unii": "23310D4I19",
    "rxcui": "397405",
    "inchikey": "OLDRWYVIKMSFFB-SSPJITILSA-N",
    "display_name": "PALONOSETRON HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "911783eb-91a8-4ef4-bd6f-809211e207d6": {
      "match": "brand_token",
      "title": "PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]",
      "spl_version": "9",
      "published_date": "2026-03-30"
    }
  },
  "productid": "69097-927_04460041-adec-463b-ba9d-6a12038ab672",
  "productndc": "69097-927",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021372",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jul 25, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 29, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALONOSETRON HYDROCHLORIDE",
  "shortage_reason": "Palonosetron Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "palonosetron hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA021372",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "palonosetron hydrochloride",
  "start_marketing_date": "20180323",
  "active_numerator_strength": ".25"
}