🇺🇸
United States · US · US:50090-6963_7a0088db-1e25-49db-9a22-c99cd6adfd8f
NALOXONE HYDROCHLORIDE
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
- ndc1150090696302 VIAL, SINGLE-DOSE in 1 CARTON (50090-6963-0) / .1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A211951
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": {
"8535cc84-ad4a-4d67-8480-fb5a2e3406f8": {
"match": "brand_token",
"title": "NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "35",
"published_date": "2026-05-28"
}
},
"productid": "50090-6963_7a0088db-1e25-49db-9a22-c99cd6adfd8f",
"productndc": "50090-6963",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "211951",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "4MG/SPRAY",
"product_no": "001",
"approval_date": "Jun 21, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "NALOXONE HYDROCHLORIDE",
"active_ingred_unit": "mg/.1mL",
"application_number": "ANDA211951",
"marketing_category": "ANDA",
"nonproprietary_name": "naloxone hydrochloride",
"start_marketing_date": "20230730",
"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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