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United States · US · US:70121-1631_4f44c872-f02d-48cc-b2a4-4e05d2422b72
TEPADINA
Orange BookUNIISPLATC L01AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121163111 VIAL, GLASS in 1 BOX (70121-1631-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
905Z5W3GKH
THIOTEPA
RxCUI 10473
Orange Book
N208264
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": {
"559e353c-2dc0-16ba-e054-00144ff8d46c": {
"match": "brand_token",
"title": "TEPADINA (THIOTEPA) INJECTION, POWDER, FOR SOLUTION TEPADINA (THIOTEPA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "30",
"published_date": "2026-02-16"
}
},
"productid": "70121-1631_4f44c872-f02d-48cc-b2a4-4e05d2422b72",
"productndc": "70121-1631",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "208264",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "15MG/VIAL",
"product_no": "001",
"approval_date": "Jan 26, 2017"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "002",
"approval_date": "Jan 26, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "Apr 10, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "400MG",
"product_no": "004",
"approval_date": "Jan 15, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "THIOTEPA",
"proprietary_name": "TEPADINA",
"active_ingred_unit": "mg/1",
"application_number": "NDA208264",
"marketing_category": "NDA",
"nonproprietary_name": "THIOTEPA",
"start_marketing_date": "20170815",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01AC01.
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