NDC 73554-3111 Zynteglo
Betibeglogene Autotemcel Suspension Intravenous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 73554-3111?
What are the uses for Zynteglo?
What are Zynteglo Active Ingredients?
Which are Zynteglo UNII Codes?
The UNII codes for the active ingredients in this product are:
- BETIBEGLOGENE AUTOTEMCEL (UNII: MEE8487RTP)
- BETIBEGLOGENE AUTOTEMCEL (UNII: MEE8487RTP) (Active Moiety)
Which are Zynteglo 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:
- CRYOSTOR CS5 (UNII: 2UT2KB9SRE)
What is the NDC to RxNorm Crosswalk for Zynteglo?
- RxCUI: 2610435 - betibeglogene autotemcel 20 ML Injection
- RxCUI: 2610435 - 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection
- RxCUI: 2610436 - zynteglo 20 ML Injection
- RxCUI: 2610436 - 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
- RxCUI: 2610436 - 20 ML Zynteglo 20000000 CELLS/ML Injection
* Please review the disclaimer below.
Patient Education
Betibeglogene autotemcel Injection
Betibeglogene autotemcel injection is used to treat anemia (a lower than normal number of red blood cells) in people who require regular blood transfusions to treat beta thalassemia (Cooley's anemia; an inherited condition that causes a low number of red blood cells). Betibeglogene autotemcel injection is in a class of medications called autologous gene therapy, a type of medication prepared using cells from the patient's own blood stem cells. It works by helping your body to produce enough red blood cells so that regular blood transfusions are not necessary.
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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".