Zolgensma Kit
NDC 71894-153
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Zolgensma (onasemnogene abeparvovec-xioi) is a BLA-approved product labeled by Novartis Gene Therapies, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 71894-153 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
71894-153
Proprietary Name:
Zolgensma
Non-Proprietary Name: [1]
Onasemnogene Abeparvovec-xioi
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
71894
Product Label ID:
FDA Application Number: [6]
BLA125694
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
05-24-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 71894-153?
The NDC code 71894-153 is assigned by the FDA to the product Zolgensma. It is commonly known by its generic name, onasemnogene abeparvovec-xioi. This pharmaceutical product is labeled by Novartis Gene Therapies, Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 71894-153-13. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
ZOLGENSMA (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.Limitation of Use •The safety and effectiveness of repeat administration of ZOLGENSMA have not been evaluated [see Adverse Reactions (6.2)].•The use of ZOLGENSMA in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see Clinical Studies (14)].
What is the NDC to RxNorm Crosswalk for this product?
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: 2170239 - onasemnogene abeparvovec-xioi 2 x 10(13) vg/ML in 5.5 ML Injection
- RxCUI: 2170239 - 5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection
- RxCUI: 2170239 - onasemnogene abeparvovec-xioi 2 x 10(13) vg/ML per 5.5 ML Injection
- RxCUI: 2170241 - Zolgensma 2.0 x 10(13) vg/ML in 5.5 ML Injection
- RxCUI: 2170241 - 5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection [Zolgensma]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
