🇺🇸
United States · US · US:84549-072_3f2bb95a-aece-c0b7-e063-6394a90a627b
Naloxone Hydrochloride
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProPharma Distribution
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11845490721010 mL in 1 VIAL, GLASS (84549-072-10)
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A207634
AP
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": "84549-072_3f2bb95a-aece-c0b7-e063-6394a90a627b",
"productndc": "84549-072",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207634",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/ML",
"product_no": "001",
"approval_date": "Jul 26, 2017"
}
],
"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": "ANDA207634",
"marketing_category": "ANDA",
"nonproprietary_name": "Naloxone Hydrochloride",
"start_marketing_date": "20170726",
"active_numerator_strength": ".4"
}Related drugs
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- 🇪🇸NALOXONA KERN PHARMA 0,4 mg/ml SOLUCION INYECTABLE Y PARA PERFUSIONKern Pharma S.L.
- GBNaloxone 1.26mg/0.1ml nasal spray unit doseAccord-UK Ltd
- GBNaloxone 1.26mg/0.1ml nasal spray unit doseA A H Pharmaceuticals Ltd
- GBNaloxone 2mg/2ml solution for injection pre-filled syringesMartindale Pharmaceuticals Ltd
- GBNaloxone 2mg/2ml solution for injection pre-filled syringesA A H Pharmaceuticals Ltd
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