🇺🇸
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
- ndc1185766076022 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"strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"
}Related drugs
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- GBNaloxone 1.26mg/0.1ml nasal spray unit doseA A H Pharmaceuticals Ltd
- GBNaloxone 2mg/2ml solution for injection pre-filled syringesMartindale Pharmaceuticals Ltd
- GBNaloxone 2mg/2ml solution for injection pre-filled syringesA A H Pharmaceuticals Ltd
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