| NDC Code | 65219-029-20 |
| Package Description | 1 VIAL in 1 CARTON (65219-029-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| Product NDC | 65219-029 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Thiotepa |
| Non-Proprietary Name | Thiotepa |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
| Start Marketing Date | 20220411 |
| Marketing Category Name | ANDA |
| Application Number | ANDA214222 |
| Manufacturer | Fresenius Kabi USA, LLC |
| Substance Name | THIOTEPA |
| Strength | 100 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |