🇺🇸
United States · US · US:70069-071_c30c2699-564b-4c18-89ec-36dfd7df3bb2
Naloxone Hydrochloride
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700690711010 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01)
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A207633
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": "70069-071_c30c2699-564b-4c18-89ec-36dfd7df3bb2",
"productndc": "70069-071",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207633",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/ML",
"product_no": "001",
"approval_date": "Aug 8, 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": "ANDA207633",
"marketing_category": "ANDA",
"nonproprietary_name": "Naloxone Hydrochloride",
"start_marketing_date": "20170808",
"active_numerator_strength": ".4"
}Related drugs
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