NDC 73554-2111 Skysona
Elivaldogene Autotemcel Suspension Intravenous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
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Product Details
What is NDC 73554-2111?
What are the uses for Skysona?
What are Skysona Active Ingredients?
Which are Skysona UNII Codes?
The UNII codes for the active ingredients in this product are:
- ELIVALDOGENE AUTOTEMCEL (UNII: KUM75TD6SG)
- ELIVALDOGENE AUTOTEMCEL (UNII: KUM75TD6SG) (Active Moiety)
What is the NDC to RxNorm Crosswalk for Skysona?
- RxCUI: 2612552 - elivaldogene autotemcel 30,000,000 CELLS/mL in 20 ML Injection
- RxCUI: 2612552 - 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection
- RxCUI: 2612552 - elivaldogene autotemcel 30,000,000 CELLS/ML per 20 ML Injection
- RxCUI: 2612558 - skysona 30,000,000 CELLS/mL in 20 ML Injection
- RxCUI: 2612558 - 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection [Skysona]
* Please review the disclaimer below.
Patient Education
Elivaldogene autotemcel Injection
Elivaldogene autotemcel injection is used to slow the progression of brain damage and slow the decline of nerve function in males 4–17 years of age with early, active cerebral adrenoleukodystrophy (CALD; an inherited condition in which fatty acids build up in the brain, resulting in nerve and brain damage). Elivaldogene autotemcel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by helping your body to break down the fatty acids and slow the progression of nerve and brain damage.
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* Please review the disclaimer below.
[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".