NDC 72511-770 Repatha

Evolocumab Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
72511-770
Proprietary Name:
Repatha
Non-Proprietary Name: [1]
Evolocumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Amgen Usa Inc.
Labeler Code:
72511
FDA Application Number: [6]
BLA125522
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
10-09-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 72511-770-01

Package Description: 1 KIT in 1 CARTON * 1 CARTRIDGE in 1 TRAY / 3.5 mL in 1 CARTRIDGE

Price per Unit: $167.64812 per ML

NDC Code 72511-770-91

Package Description: 1 KIT in 1 CARTON * 1 CARTRIDGE in 1 TRAY / 3.5 mL in 1 CARTRIDGE

Product Details

What is NDC 72511-770?

The NDC code 72511-770 is assigned by the FDA to the product Repatha which is a human prescription drug product labeled by Amgen Usa Inc.. The generic name of Repatha is evolocumab. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 72511-770-01 1 kit in 1 carton * 1 cartridge in 1 tray / 3.5 ml in 1 cartridge, 72511-770-91 1 kit in 1 carton * 1 cartridge in 1 tray / 3.5 ml in 1 cartridge. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Repatha?

Evolocumab is used to help lower "bad" cholesterol (LDL) in the blood. For people who have high levels of LDL, it is used along with a proper diet, alone or other LDL-lowering treatments (such as "statin" drugs, ezetimibe, LDL apheresis). Evolocumab is also used by people who have heart disease to help prevent heart attacks and strokes. This medication belongs to a class of drugs known as monoclonal antibodies. It works by improving how well your body gets rid of LDL cholesterol. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Which are Repatha UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Repatha Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Repatha?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Evolocumab Injection


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.
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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".