🇺🇸
United States · US · US:60219-2104_a79738c5-1989-43c7-856b-f284c654c9c0
Naloxone Hydrochloride
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160219210472 VIAL in 1 CARTON (60219-2104-7) / .1 mL in 1 VIAL (60219-2104-1)
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A217992
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": "60219-2104_a79738c5-1989-43c7-856b-f284c654c9c0",
"productndc": "60219-2104",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "217992",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "4MG/SPRAY",
"product_no": "001",
"approval_date": "Apr 23, 2024"
}
],
"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": "ANDA217992",
"marketing_category": "ANDA",
"nonproprietary_name": "Naloxone",
"start_marketing_date": "20240424",
"active_numerator_strength": "4"
}Related drugs
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