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United States · US · US:68083-503_164faf7b-519a-41f7-a760-eb2a81b9f040
Thiotepa
Orange BookUNIISPLATC L01AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083503011 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
905Z5W3GKH
THIOTEPA
RxCUI 10473
Orange Book
A214222
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": "68083-503_164faf7b-519a-41f7-a760-eb2a81b9f040",
"productndc": "68083-503",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "214222",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "15MG/VIAL",
"product_no": "001",
"approval_date": "Mar 8, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "002",
"approval_date": "Jan 3, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "THIOTEPA",
"proprietary_name": "Thiotepa",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214222",
"marketing_category": "ANDA",
"nonproprietary_name": "Thiotepa",
"start_marketing_date": "20220103",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01AC01.
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