🇺🇸
United States · US · US:50090-2422_caf3eabb-89bd-469a-9d00-3fd3a18fb5db
NARCAN
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090242202 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-2422-0) / .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": "50090-2422_caf3eabb-89bd-469a-9d00-3fd3a18fb5db",
"productndc": "50090-2422",
"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"strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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
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- GBNaloxone 1.26mg/0.1ml nasal spray unit doseA A H Pharmaceuticals Ltd
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- GBNaloxone 2mg/2ml solution for injection pre-filled syringesA A H Pharmaceuticals Ltd
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