🇺🇸
United States · US · US:72205-046_fa8d1c84-357b-433d-8f78-89175c9a8cbc
Thiotepa
Orange BookUNIISPLATC L01AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172205046011 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
905Z5W3GKH
THIOTEPA
RxCUI 10473
Orange Book
A213049
APAP
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": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"spl_meta": {
"6cd6ae89-c553-4328-9262-4363610a1f19": {
"match": "brand_token",
"title": "THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]",
"spl_version": "7",
"published_date": "2026-01-26"
}
},
"productid": "72205-046_fa8d1c84-357b-433d-8f78-89175c9a8cbc",
"productndc": "72205-046",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "213049",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "15MG/VIAL",
"product_no": "001",
"approval_date": "Mar 4, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "002",
"approval_date": "Mar 4, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "THIOTEPA",
"proprietary_name": "Thiotepa",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213049",
"marketing_category": "ANDA",
"nonproprietary_name": "Thiotepa",
"start_marketing_date": "20200201",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01AC01.
Access this data programmatically
Query Thiotepa and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.