| Product NDC: | 53964-002 |
| Proprietary Name: | TEPADINA |
| Non Proprietary Name: | THIOTEPA |
| Active Ingredient(s): | 100 mg/1 & nbsp; THIOTEPA |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 53964-002 |
| Labeler Name: | ADIENNE SA |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | |
| Marketing Category: | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Start Marketing Date: | 20110405 |
| Package NDC: | 53964-002-02 |
| Package Description: | 1 VIAL, GLASS in 1 BOX (53964-002-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| NDC Code | 53964-002-02 |
| Proprietary Name | TEPADINA |
| Package Description | 1 VIAL, GLASS in 1 BOX (53964-002-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| Product NDC | 53964-002 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | THIOTEPA |
| Dosage Form Name | INJECTION, POWDER, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20110405 |
| Marketing Category Name | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| Labeler Name | ADIENNE SA |
| Substance Name | THIOTEPA |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |