Naloxone Hydrochloride

{
  "unii": {
    "unii": "F850569PQR",
    "rxcui": "203192",
    "inchikey": "RGPDIGOSVORSAK-STHHAXOLSA-N",
    "display_name": "NALOXONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "8535cc84-ad4a-4d67-8480-fb5a2e3406f8": {
      "match": "brand_token",
      "title": "NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "35",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50090-5908_fefa320d-95d8-414e-ad54-40c9f6d2c55d",
  "productndc": "50090-5908",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "208411",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG/SPRAY",
        "product_no": "001",
        "approval_date": "Nov 18, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jan 24, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "Naloxone Hydrochloride",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA208411",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Naloxone Hydrochloride Nasal",
  "start_marketing_date": "20211220",
  "active_numerator_strength": "4"
}