🇺🇸
United States · US · US:60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8
Naloxone Hydrochloride Injection, USP, Auto-Injector
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKaleo, Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11608420020210 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
N215457
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": "INTRAMUSCULAR; SUBCUTANEOUS",
"spl_meta": {
"8535cc84-ad4a-4d67-8480-fb5a2e3406f8": {
"match": "brand_token",
"title": "NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "35",
"published_date": "2026-05-28"
}
},
"productid": "60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8",
"productndc": "60842-002",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "215457",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG/0.4ML (10MG/0.4ML)",
"product_no": "001",
"approval_date": "Feb 28, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "Naloxone Hydrochloride Injection, USP, Auto-Injector",
"active_ingred_unit": "mg/.4mL",
"application_number": "NDA215457",
"marketing_category": "NDA",
"nonproprietary_name": "Naloxone Hydrochloride",
"start_marketing_date": "20220228",
"active_numerator_strength": "10"
}Related drugs
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