🇺🇸
United States · US · US:43066-142_48137634-91d7-41e3-b54b-e4321d69668a
naloxone hydrochloride
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11430661421010 CARTON in 1 CARTON (43066-142-10) / 1 SYRINGE, GLASS in 1 CARTON (43066-142-01) / 2 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A214785
APAP
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; INTRAVENOUS; 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": "43066-142_48137634-91d7-41e3-b54b-e4321d69668a",
"productndc": "43066-142",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214785",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/ML",
"product_no": "001",
"approval_date": "Jan 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "002",
"approval_date": "Jun 3, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "naloxone hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214785",
"marketing_category": "ANDA",
"nonproprietary_name": "naloxone hydrochloride",
"start_marketing_date": "20250603",
"active_numerator_strength": "1"
}Related drugs
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