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United States · US · US:81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9
TEPYLUTE
Orange BookUNIISPLATC L01AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerShorla Oncology Inc.
CountryUS (United States)
ATC codeL01AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1181927106011 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01) / 10 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
905Z5W3GKH
THIOTEPA
RxCUI 10473
Orange Book
N216984
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "905Z5W3GKH",
"rxcui": "10473",
"inchikey": "FOCVUCIESVLUNU-UHFFFAOYSA-N",
"display_name": "THIOTEPA",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"add44e98-a042-4e38-b870-beb36693805b": {
"match": "brand_token",
"title": "TEPYLUTE (THIOTEPA) INJECTION [SHORLA ONCOLOGY INC.]",
"spl_version": "4",
"published_date": "2025-12-22"
}
},
"productid": "81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9",
"productndc": "81927-106",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216984",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "15MG/1.5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Jun 25, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/10ML (10MG/ML)",
"product_no": "002",
"approval_date": "Feb 26, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "THIOTEPA",
"proprietary_name": "TEPYLUTE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA216984",
"marketing_category": "NDA",
"nonproprietary_name": "thiotepa",
"start_marketing_date": "20250331",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L01AC01.
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