🇺🇸
United States · US · US:0480-3478_7545d296-ad3c-4be1-9913-73b4f870e90c
Naloxone Hydrochloride
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104803478682 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A209522
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": "0480-3478_7545d296-ad3c-4be1-9913-73b4f870e90c",
"productndc": "0480-3478",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "209522",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "4MG/SPRAY",
"product_no": "001",
"approval_date": "Apr 19, 2019"
}
],
"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": "ANDA209522",
"marketing_category": "ANDA",
"nonproprietary_name": "Naloxone Hydrochloride",
"start_marketing_date": "20240923",
"active_numerator_strength": "4"
}Related drugs
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