| NDC Code | 70121-2749-1 |
| Package Description | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1) |
| Product NDC | 70121-2749 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Tepadina |
| Non-Proprietary Name | Thiotepa |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
| Start Marketing Date | 20250418 |
| Marketing Category Name | NDA |
| Application Number | NDA208264 |
| Manufacturer | Amneal Pharmaceuticals LLC |
| Substance Name | THIOTEPA |
| Strength | 200 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |