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United States · US · US:69547-627_e1bd0aff-d415-4118-8af7-87ce6dc54bd4

NARCAN

Orange BookUNIISPLATC A06AH04

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

Identification

ManufacturerEmergent Devices Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6954762702
    2 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6954762705
    1 CASE in 1 CARTON (69547-627-05) / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6954762706
    6 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-06) / .1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6954762724
    24 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-24) / .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": "69547-627_e1bd0aff-d415-4118-8af7-87ce6dc54bd4",
  "productndc": "69547-627",
  "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        "strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"
}

Related drugs

Other records sharing ATC code A06AH04.

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