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United States · US · US:83107-030_4c20479c-d75a-a0c7-e063-6394a90a9e59
Ethyol
Orange BookUNIISPLATC V03AF05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLegacy Pharma USA Inc.
CountryUS (United States)
ATC codeV03AF05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183107030023 VIAL, SINGLE-DOSE in 1 CARTON (83107-030-02) / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01)
Annotations
UNII (FDA Substance ID)
M487QF2F4V
AMIFOSTINE
RxCUI 4126
Orange Book
N020221
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M487QF2F4V",
"rxcui": "4126",
"inchikey": "TXQPXJKRNHJWAX-UHFFFAOYSA-N",
"display_name": "AMIFOSTINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"a17563f2-d231-4385-bc94-0217be78b89d": {
"match": "brand_token",
"title": "ETHYOL (AMIFOSTINE) INJECTION [LEGACY PHARMA USA INC.]",
"spl_version": "2",
"published_date": "2026-03-16"
}
},
"productid": "83107-030_4c20479c-d75a-a0c7-e063-6394a90a9e59",
"productndc": "83107-030",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "020221",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Dec 8, 1995"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "375MG/VIAL",
"product_no": "002",
"approval_date": "Sep 10, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIFOSTINE",
"proprietary_name": "Ethyol",
"active_ingred_unit": "mg/10mL",
"application_number": "NDA020221",
"marketing_category": "NDA",
"nonproprietary_name": "Amifostine",
"start_marketing_date": "20260316",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code V03AF05.
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