NDC 0024-5901 Praluent

Alirocumab Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0024-5901
Proprietary Name:
Praluent
Non-Proprietary Name: [1]
Alirocumab
Substance Name: [2]
Alirocumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Sanofi-aventis U.s. Llc
    Labeler Code:
    0024
    FDA Application Number: [6]
    BLA125559
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    07-24-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0024-5901-00

    Package Description: 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

    NDC Code 0024-5901-01

    Package Description: 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

    NDC Code 0024-5901-02

    Package Description: 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

    Price per Unit: $540.47100 per ML

    Product Details

    What is NDC 0024-5901?

    The NDC code 0024-5901 is assigned by the FDA to the product Praluent which is a human prescription drug product labeled by Sanofi-aventis U.s. Llc. The generic name of Praluent is alirocumab. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 3 packages with assigned NDC codes 0024-5901-00 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass, 0024-5901-01 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass, 0024-5901-02 2 syringe, glass in 1 carton / 1 ml in 1 syringe, glass. 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 Praluent?

    Alirocumab is used by people who have blockage in the heart blood vessels to reduce the risk of heart attack, stroke, and certain types of chest pain that require treatment in a hospital. It is also used by people who have an inherited condition that causes high levels of LDL. Treatment with alirocumab, a proper diet, and cholesterol-lowering drugs can help lower "bad" cholesterol (LDL) in the blood. Alirocumab 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.

    What are Praluent Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Praluent UNII Codes?

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

    Which are Praluent 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 Praluent?

    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:

    Which are the Pharmacologic Classes for Praluent?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Alirocumab Injection


    Alirocumab injection is used along with diet, alone or in combination with other cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins] or ezetimibe [Zetia, in Liptruzet, in Vytorin]), in adults who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally) to decrease the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood. It is also used in adults with cardiovascular disease to lower the risk of stroke, heart attack, or serious or life-threatening chest pain. Alirocumab injection is also used with other medications to treat homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally) in adults to decrease LDL cholesterol. Alirocumab injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibodies. It works by blocking the production of LDL cholesterol in the body therefore decreasing the amount of cholesterol that may build up on the walls of the arteries. 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.
    [Learn More]


    * Please review the disclaimer below.

    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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".