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NDC 55513-0770-91 REPATHA Details
REPATHA
REPATHA is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is .
MedlinePlus Drug Summary
Evolocumab injection is used to reduce the risk of a stroke or heart attack or the need for coronary artery bypass (CABG) surgery in people with cardiovascular disease. Evolocumab injection is also used along with diet alone or in combination with other cholesterol-lowering medications such as HMG-CoA reductase inhibitors (statins) or ezetimbe (Zetia) to decrease the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood, including people who have familial heterozygous hypercholesterolemia (HeFH; an inherited condition in which cholesterol cannot be removed from the body normally). It is also used along with diet changes and other treatments to reduce the amount low-density lipoprotein (LDL) cholesterol ('bad cholesterol')in the blood in people that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). Evolocumab injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibody. It works by blocking the production of LDL cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. Accumulation of cholesterol along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body.
Related Packages: 55513-0770-91Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Evolocumab Injection
Product Information
NDC | 55513-0770 |
---|---|
Product ID | 55513-770_ad0cad06-6727-4812-89f4-beb4f2e92a5c |
Associated GPIs | |
GCN Sequence Number | 076353 |
GCN Sequence Number Description | evolocumab WEAR INJCT 420 MG/3.5 SUBCUT |
HIC3 | M4T |
HIC3 Description | ANTIHYPERLIPIDEMIC - PCSK9 INHIBITORS |
GCN | 41834 |
HICL Sequence Number | 042378 |
HICL Sequence Number Description | EVOLOCUMAB |
Brand/Generic | Brand |
Proprietary Name | REPATHA |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Evolocumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | KIT |
Route | n/a |
Active Ingredient Strength | n/a |
Active Ingredient Units | n/a |
Substance Name | n/a |
Labeler Name | Amgen Inc |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125522 |
Listing Certified Through | 2024-12-31 |
Package
NDC 55513-0770-91 (55513077091)
NDC Package Code | 55513-770-91 |
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Billing NDC | 55513077091 |
Package | 1 KIT in 1 CARTON (55513-770-91) * 1 CARTRIDGE in 1 TRAY / 3.5 mL in 1 CARTRIDGE |
Marketing Start Date | 2016-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |