NDC 0074-0038 Orilissa

Elagolix Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0074-0038
Proprietary Name:
Orilissa
Non-Proprietary Name: [1]
Elagolix
Substance Name: [2]
Elagolix Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Abbvie Inc.
    Labeler Code:
    0074
    FDA Application Number: [6]
    NDA210450
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-23-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - LIGHT PINK)
    Shape:
    OVAL (C48345)
    Size(s):
    14 MM
    Imprint(s):
    EL;150
    Score:
    1

    Product Packages

    NDC Code 0074-0038-07

    Package Description: 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 0074-0038-28

    Package Description: 4 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK

    Price per Unit: $39.85018 per EA

    Product Details

    What is NDC 0074-0038?

    The NDC code 0074-0038 is assigned by the FDA to the product Orilissa which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Orilissa is elagolix. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0074-0038-07 1 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack, 0074-0038-28 4 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack. 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 Orilissa?

    This medication is used by women to help relieve moderate to severe pain due to a condition called endometriosis. Endometriosis is the growth of tissue that normally lines the inside of the womb (uterus) in a different place, such as on the outside surface of the uterus, on the ovaries, or on other organs. This condition may cause symptoms such as painful/heavy/irregular menstrual periods, pain during or after sex, or infertility. Elagolix works by decreasing your body's production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). These lower levels may help decrease some symptoms of endometriosis.

    What are Orilissa 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 Orilissa UNII Codes?

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

    Which are Orilissa 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 Orilissa?

    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 Orilissa?

    * Please review the disclaimer below.

    Patient Education

    Elagolix


    Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding). Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the 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".