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NDC 70121-1631-01 TEPADINA 100 mg/1 Details
TEPADINA 100 mg/1
TEPADINA is a INTRACAVITARY; INTRAVENOUS; INTRAVESICAL INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is THIOTEPA.
MedlinePlus Drug Summary
Thiotepa is used to treat certain types of ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), breast, and bladder cancer. It is also used to treat malignant effusions (a condition when fluid collects in the lungs or around the heart) that are caused by cancerous tumors. Thiotepa is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 70121-1631-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Thiotepa Injection
Product Information
| NDC | 70121-1631 |
|---|---|
| Product ID | 70121-1631_efb00209-b6cb-4f50-9546-b0ea0e4db28f |
| Associated GPIs | 21100040002150 |
| GCN Sequence Number | 066744 |
| GCN Sequence Number Description | thiotepa VIAL 100 MG INJECTION |
| HIC3 | V1A |
| HIC3 Description | ANTINEOPLASTIC - ALKYLATING AGENTS |
| GCN | 29119 |
| HICL Sequence Number | 003898 |
| HICL Sequence Number Description | THIOTEPA |
| Brand/Generic | Brand |
| Proprietary Name | TEPADINA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | THIOTEPA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
| Route | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | THIOTEPA |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208264 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70121-1631-01 (70121163101)
| NDC Package Code | 70121-1631-1 |
|---|---|
| Billing NDC | 70121163101 |
| Package | 1 VIAL, GLASS in 1 BOX (70121-1631-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| Marketing Start Date | 2017-08-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |