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United States · US · US:71288-156_d75a277e-a2ff-4409-8ef3-34b7fd2198f1
Thiotepa
Orange BookUNIISPLATC L01AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc
CountryUS (United States)
ATC codeL01AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288156051 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
905Z5W3GKH
THIOTEPA
RxCUI 10473
Orange Book
A216037
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": "71288-156_d75a277e-a2ff-4409-8ef3-34b7fd2198f1",
"productndc": "71288-156",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "216037",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "15MG/VIAL",
"product_no": "001",
"approval_date": "Dec 26, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "002",
"approval_date": "Dec 26, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "THIOTEPA",
"proprietary_name": "Thiotepa",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216037",
"marketing_category": "ANDA",
"nonproprietary_name": "Thiotepa",
"start_marketing_date": "20231226",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code L01AC01.
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