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United States · US · US:59467-679_da424329-9a63-4df3-bced-4157d2086e20
KLOXXADO
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Specialty USA Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115946767901.1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01)
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
N212045
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": {
"ebf0f833-c1c0-487c-8f29-01fa8c61b6cb": {
"match": "brand_token",
"title": "KLOXXADO (NALOXONE HCL) SPRAY [HIKMA SPECIALTY USA INC.]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "59467-679_da424329-9a63-4df3-bced-4157d2086e20",
"productndc": "59467-679",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "212045",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "8MG/SPRAY",
"product_no": "001",
"approval_date": "Apr 29, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "4MG/SPRAY",
"product_no": "002",
"approval_date": "Aug 25, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "KLOXXADO",
"active_ingred_unit": "mg/.1mL",
"application_number": "NDA212045",
"marketing_category": "NDA",
"nonproprietary_name": "Naloxone HCL",
"start_marketing_date": "20210803",
"active_numerator_strength": "8"
}Related drugs
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- GBNaloxone 2mg/5ml solution for injection Minijet pre-filled syringesUCB Pharma Ltd
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