🇺🇸
United States · US · US:46122-812_7232f412-39b6-47d5-8f9a-0c1559435a3f
NALOXONE HYDROCHLORIDE
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAMERISOURCE BERGEN
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1146122812712 VIAL, SINGLE-DOSE in 1 CARTON (46122-812-71) / .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": "46122-812_7232f412-39b6-47d5-8f9a-0c1559435a3f",
"productndc": "46122-812",
"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": "20250312",
"active_numerator_strength": "4"
}Related drugs
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