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NDC 65597-0406-01 Enhertu 100 mg/5mL Details
Enhertu 100 mg/5mL
Enhertu is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Daiichi Sankyo, Inc.. The primary component is TRASTUZUMAB DERUXTECAN.
MedlinePlus Drug Summary
Fam-trastuzumab deruxtecan-nxki injection is used to treat a certain type of breast cancer that cannot be removed by surgery, that has spread to other parts of the body, or has come back after another breast cancer treatment. It is also used to treat certain types of gastric cancer (cancer of the stomach) in adults that has spread to nearby tissues or to other parts of the body after receiving another treatment. Fam-trastuzumab deruxtecan-nxki injection is also used to treat a certain type of non-small cell lung cancer (NSCLC) in adults that cannot be removed by surgery or that has spread to other parts of the body after receiving another treatment. Fam-trastuzumab deruxtecan-nxki is in a class of medications called antibody-drug conjugates. It works by killing cancer cells.
Related Packages: 65597-0406-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fam-trastuzumab deruxtecan-nxki Injection
Trastuzumab injection products are used with other medications or after other medications have been used to treat a certain type of breast cancer that has spread to other parts of the body. Trastuzumab injection products are also used during and after treatment with other medications to decrease the chance that a certain type of breast cancer will return. Trastuzumab injection products are also used with other medications to treat certain types of stomach cancer that have spread to other parts of the body. Trastuzumab is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells.
Related Packages: 65597-0406-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Trastuzumab Injection
Product Information
| NDC | 65597-0406 |
|---|---|
| Product ID | 65597-406_b07983c7-f76f-490c-8a07-622b95044abd |
| Associated GPIs | 21355070552120 |
| GCN Sequence Number | 080576 |
| GCN Sequence Number Description | fam-trastuzumab deruxtecn-nxki VIAL 100 MG INTRAVEN |
| HIC3 | V1K |
| HIC3 Description | ANTINEOPLASTICS ANTIBODY/ANTIBODY-DRUG COMPLEXES |
| GCN | 47458 |
| HICL Sequence Number | 046262 |
| HICL Sequence Number Description | FAM-TRASTUZUMAB DERUXTECAN-NXKI |
| Brand/Generic | Brand |
| Proprietary Name | Enhertu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fam-trastuzumab deruxtecan-nxki |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5mL |
| Substance Name | TRASTUZUMAB DERUXTECAN |
| Labeler Name | Daiichi Sankyo, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761139 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65597-0406-01 (65597040601)
| NDC Package Code | 65597-406-01 |
|---|---|
| Billing NDC | 65597040601 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2019-12-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |