🇺🇸
United States · US · US:39822-4510_52e223c0-963d-7d55-e063-6294a90abfcb
edaravone
Orange BookUNIISPLATC N07XX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeN07XX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1139822451011 VIAL, SINGLE-DOSE in 1 CARTON (39822-4510-1) / 100 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
S798V6YJRP
EDARAVONE
RxCUI 1921877
Orange Book
A217565
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "S798V6YJRP",
"rxcui": "1921877",
"inchikey": "QELUYTUMUWHWMC-UHFFFAOYSA-N",
"display_name": "EDARAVONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"a8245a98-2ccb-4062-b865-3aa348351b48": {
"match": "brand_token",
"title": "EDARAVONE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]",
"spl_version": "4",
"published_date": "2026-05-29"
}
},
"productid": "39822-4510_52e223c0-963d-7d55-e063-6294a90abfcb",
"productndc": "39822-4510",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217565",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "30MG/100ML (0.3MG/ML)",
"product_no": "001",
"approval_date": "Oct 31, 2024"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "60MG/100ML (0.6MG/ML)",
"product_no": "002",
"approval_date": "Oct 31, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EDARAVONE",
"proprietary_name": "edaravone",
"active_ingred_unit": "mg/100mL",
"application_number": "ANDA217565",
"marketing_category": "ANDA",
"nonproprietary_name": "edaravone",
"start_marketing_date": "20241202",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N07XX14.
Access this data programmatically
Query edaravone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.