🇺🇸
United States · US · US:76336-080_40a4cc96-c834-c03b-e063-6394a90a01d1
Lysodren
Orange BookUNIISPLATC L01XX23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHRA Pharma Rare Diseases
CountryUS (United States)
ATC codeL01XX23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176336080601 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
78E4J5IB5J
MITOTANE
RxCUI 7004
Orange Book
N016885
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "78E4J5IB5J",
"rxcui": "7004",
"inchikey": "JWBOIMRXGHLCPP-UHFFFAOYSA-N",
"display_name": "MITOTANE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4046a224-8832-daa2-e063-6294a90a11d7": {
"match": "brand_token",
"title": "LYSODREN (MITOTANE) TABLET [ESTEVE PHARMACEUTICALS, S.A.]",
"spl_version": "17",
"published_date": "2026-05-25"
}
},
"productid": "76336-080_40a4cc96-c834-c03b-e063-6394a90a01d1",
"productndc": "76336-080",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "016885",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MITOTANE",
"proprietary_name": "Lysodren",
"active_ingred_unit": "mg/1",
"application_number": "NDA016885",
"marketing_category": "NDA",
"nonproprietary_name": "mitotane",
"start_marketing_date": "19781015",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code L01XX23.
- FILysodrenEsteve Pharmaceuticals, S.A
- ISLysodrenEsteve Pharmaceuticals S.A.
- PLLysodrenHRA Pharma Rare Diseases
- 🇺🇸LysodrenESTEVE PHARMACEUTICALS, S.A.
- DKLysodrenEsteve Pharmaceuticals S.A.
- NOLysodrenEsteve Pharmaceuticals S.A
- CALYSODRENHRA PHARMA RARE DISEASES
- CZLYSODRENEsteve Pharmaceuticals S.A., Barcelona
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