Back to search
🇺🇸

United States · US · US:71205-528_9f01f1ed-3bba-4243-8306-114d90da372b

Narcan

Orange BookUNIISPLATC A06AH04

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7120552802
    2 VIAL, SINGLE-DOSE in 1 PACKAGE (71205-528-02) / .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": "71205-528_9f01f1ed-3bba-4243-8306-114d90da372b",
  "productndc": "71205-528",
  "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        "strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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 PRESCRIPTION DRUG",
  "substance_name": "NALOXONE HYDROCHLORIDE",
  "proprietary_name": "Narcan",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA208411",
  "marketing_category": "NDA",
  "nonproprietary_name": "Naloxone Hydrochloride",
  "start_marketing_date": "20170124",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code A06AH04.

Access this data programmatically

Query Narcan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.