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United States · US · US:68083-500_57566e6e-e90a-4fdf-b23c-d8af19893fd2
edaravone
Orange BookUNIISPLATC N07XX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeN07XX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083500022 POUCH in 1 CARTON (68083-500-02) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
S798V6YJRP
EDARAVONE
RxCUI 1921877
Orange Book
A216199
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": "68083-500_57566e6e-e90a-4fdf-b23c-d8af19893fd2",
"productndc": "68083-500",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216199",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "30MG/100ML (0.3MG/ML)",
"product_no": "001",
"approval_date": "May 6, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG/100ML (0.6MG/ML)",
"product_no": "002",
"approval_date": "May 6, 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": "ANDA216199",
"marketing_category": "ANDA",
"nonproprietary_name": "edaravone",
"start_marketing_date": "20240506",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N07XX14.
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