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United States · US · US:85766-076_50317ec7-5f58-b35a-e063-6394a90a7303

NARCAN

Orange BookUNIISPLATC A06AH04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8576607602
    2 VIAL, SINGLE-DOSE in 1 CARTON (85766-076-02) / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
N208411
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "F850569PQR",
    "rxcui": "203192",
    "inchikey": "RGPDIGOSVORSAK-STHHAXOLSA-N",
    "display_name": "NALOXONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "a0ebc83d-2892-40de-bc0a-775ce90b30db": {
      "match": "brand_token",
      "title": "NARCAN (NALOXONE HYDROCHLORIDE NASAL) SPRAY [EMERGENT DEVICES INC.]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "85766-076_50317ec7-5f58-b35a-e063-6394a90a7303",
  "productndc": "85766-076",
  "dosage_form": "SPRAY",
  "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        "strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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 OTC DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "NARCAN",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA208411",
  "marketing_category": "NDA",
  "nonproprietary_name": "naloxone hydrochloride nasal",
  "start_marketing_date": "20230828",
  "active_numerator_strength": "4"
}

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