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  4. NDC Product Code: 73079-075 Zokinvy

NDC 73079-075 Zokinvy

Lonafarnib Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 73079-075?
  5. Zokinvy Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
73079-075
Proprietary Name:
Zokinvy
Non-Proprietary Name: [1]
Lonafarnib
Substance Name: [2]
Lonafarnib
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Eiger Biopharmaceuticals, Inc.
    Labeler Code:
    73079
    Product Label ID:
    956a142f-35d6-4fe3-8aef-7e4878d275ed
    FDA Application Number: [6]
    NDA213969
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-20-2020
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - OPAQUE YELLOW)
    ORANGE (C48331 - OPAQUE LIGHT ORANGE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    12 MM
    14 MM
    Imprint(s):
    LNF;50
    LNF;75
    Score:
    1

    Product Packages

    NDC Code 73079-075-30

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 30 CAPSULE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 73079-075?

    The NDC code 73079-075 is assigned by the FDA to the product Zokinvy which is a human prescription drug product labeled by Eiger Biopharmaceuticals, Inc.. The generic name of Zokinvy is lonafarnib. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 73079-075-30 1 bottle, plastic in 1 carton / 30 capsule in 1 bottle, plastic. 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 Zokinvy?

    ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS)For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulationHomozygous or compound heterozygous ZMPSTE24 mutations Limitations of UseZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.

    What are Zokinvy 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 Zokinvy UNII Codes?

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

    Which are Zokinvy 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 Zokinvy?

    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 Zokinvy?

    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

    Lonafarnib


    Lonafarnib is used to reduce the risk of death in children 1 year of age or older with Hutchinson-Gilford progeria syndrome (HGPS, Hutchinson-Gilford syndrome; an inherited disorder that causes certain proteins to build up in the body which causes children to age rapidly). Lonafarnib is also used to treat certain processing-deficient progeroid laminopathies (PDPL; inherited disorders that cause certain proteins to build up in the body which cause children to age rapidly). Lonafarnib is in a class of medications called farnesyltransferase inhibitors. It works by preventing proteins from building up and damaging cells.
    [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".