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United States · US · US:0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39a
Edaravone
Orange BookUNIISPLATC N07XX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN07XX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107813527202 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94)
Annotations
UNII (FDA Substance ID)
S798V6YJRP
EDARAVONE
RxCUI 1921877
Orange Book
A216902
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": "0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39a",
"productndc": "0781-3527",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216902",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "30MG/100ML (0.3MG/ML)",
"product_no": "001",
"approval_date": "Dec 23, 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": "ANDA216902",
"marketing_category": "ANDA",
"nonproprietary_name": "Edaravone",
"start_marketing_date": "20250121",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N07XX14.
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