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NDC 63850-0063-06 Everolimus 0.5 mg/1 Details

Everolimus 0.5 mg/1

Everolimus is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Natco Pharma Limited. 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: 63850-0063-06
Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Everolimus

Product Information

NDC	63850-0063
Product ID	63850-0063_ab421697-aaf4-48ac-97b0-1a63cfd71942
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	0.5
Active Ingredient Units	mg/1
Substance Name	EVEROLIMUS
Labeler Name	Natco Pharma Limited
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	ANDA205432
Listing Certified Through	2024-12-31

Package

NDC 63850-0063-06 (63850006306)

Pricing Information	N/A
NDC Package Code	63850-0063-6
Billing NDC	63850006306
Package	60 TABLET in 1 BOTTLE (63850-0063-6)
Marketing Start Date	2023-05-26
NDC Exclude Flag	N