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  4. NDC Product Code: 83222-0200 Lenmeldy

NDC 83222-0200 Lenmeldy

Atidarsagene Autotemcel Suspension Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83222-0200?
  4. Lenmeldy Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
83222-0200
Proprietary Name:
Lenmeldy
Non-Proprietary Name: [1]
Atidarsagene Autotemcel
Substance Name: [2]
Atidarsagene Autotemcel
NDC Directory Status:
Cellular Therapy
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Orchard Therapeutics (europe) Ltd
    Labeler Code:
    83222
    Product Label ID:
    b3e307a7-561b-43b6-a784-9cb1dcfc5196
    FDA Application Number: [6]
    BLA125758
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-26-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 83222-0200?

    The NDC code 83222-0200 is assigned by the FDA to the product Lenmeldy which is a cellular therapy product labeled by Orchard Therapeutics (europe) Ltd. The generic name of Lenmeldy is atidarsagene autotemcel. The product's dosage form is suspension and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 83222-0200-1 1 suspension in 1 bag . 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 Lenmeldy?

    LENMELDY is indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).

    What are Lenmeldy 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 Lenmeldy UNII Codes?

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

    • ATIDARSAGENE AUTOTEMCEL (UNII: EPP8G99QG4)
    • ATIDARSAGENE AUTOTEMCEL (UNII: EPP8G99QG4) (Active Moiety)

    Which are Lenmeldy 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 Lenmeldy?

    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:
    • RxCUI: 2677920 - atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection
    • RxCUI: 2677920 - 10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection
    • RxCUI: 2677920 - atidarsagene autotemcel 11,800,000 CELLS/ML per 10 ML Injection
    • RxCUI: 2677926 - lenmeldy 11,800,000 CELLS/ML in 10 ML Injection
    • RxCUI: 2677926 - 10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection [Lenmeldy]

    * 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".