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United States · US · US:51662-1642_11d770b8-b769-ba3d-e063-6394a90a61a6

Narcan Naloxone HCL

Orange BookUNIISPLATC A06AH04

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5166216422
    2 VIAL, SINGLE-DOSE in 1 CARTON (51662-1642-2) / .1 mL in 1 VIAL, SINGLE-DOSE (51662-1642-1)

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": "51662-1642_11d770b8-b769-ba3d-e063-6394a90a61a6",
  "productndc": "51662-1642",
  "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        "strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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 Naloxone HCL",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA208411",
  "marketing_category": "NDA",
  "nonproprietary_name": "Narcan Naloxone HCL",
  "start_marketing_date": "20230828",
  "active_numerator_strength": "4"
}

Related drugs

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