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NDC 00378-3097-85 everolimus 5 mg/1 Details
everolimus 5 mg/1
everolimus is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is EVEROLIMUS.
MedlinePlus Drug Summary
Everolimus (Afinitor) is used to treat advanced renal cell carcinoma (RCC; cancer that begins in the kidneys) that has already been treated unsuccessfully with other medications. Everolimus (Afinitor) is also used to treat a certain type of advanced breast cancer that has already been treated with at least one other medication. Everolimus (Afinitor) is also used to treat a certain type of cancer of the pancreas, stomach, intestines, or lungs that has spread or progressed and that cannot be treated with surgery. Everolimus (Afinitor) is also used to treat kidney tumors in people with tuberous sclerosis complex (TSC; a genetic condition that causes tumors to grow in many organs). Everolimus (Afinitor and Afinitor Disperz) is also used to treat subependymal giant cell astrocytoma (SEGA; a type of brain tumor) in adults and children 1 year of age and older who have TSC. Everolimus (Afinitor Disperz) is also used along with other medications to treat certain types of seizures in adults and children 2 years of age and older who have TSC. Everolimus (Zortress) is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person who received the organ) in certain adults who have received kidney transplants. Everolimus is in a class of medications called kinase inhibitors. Everolimus treats cancer by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Everolimus prevents transplant rejection by decreasing the activity of the immune system.
Related Packages: 00378-3097-85Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Everolimus
Product Information
| NDC | 00378-3097 |
|---|---|
| Product ID | 0378-3097_3b66e028-99fb-44e4-9c15-288f30b64708 |
| Associated GPIs | 21532530000320 |
| GCN Sequence Number | 064994 |
| GCN Sequence Number Description | everolimus TABLET 5 MG ORAL |
| HIC3 | V3C |
| HIC3 Description | ANTINEOPLASTIC - MTOR KINASE INHIBITORS |
| GCN | 20784 |
| HICL Sequence Number | 032975 |
| HICL Sequence Number Description | EVEROLIMUS |
| Brand/Generic | Generic |
| Proprietary Name | everolimus |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | everolimus |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | EVEROLIMUS |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212936 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-3097-85 (00378309785)
| NDC Package Code | 0378-3097-85 |
|---|---|
| Billing NDC | 00378309785 |
| Package | 4 BLISTER PACK in 1 CARTON (0378-3097-85) / 7 TABLET in 1 BLISTER PACK (0378-3097-32) |
| Marketing Start Date | 2022-12-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |