Zolgensma Kit
NDC Package 71894-151-13

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zolgensma (onasemnogene abeparvovec-xioi) kits is 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)]. This formulation utilizes a kit delivery system. Marketed by Novartis Gene Therapies, Inc., this product is identified by NDC 71894-151 and is authorized under FDA application BLA125694.

Identification & Billing

NDC Package Code
71894-151-13
Package Description
1 KIT in 1 CARTON * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01)
Product Code
71894-151
11-Digit Billing Format
71894015113
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Zolgensma
Non-Proprietary Name
Onasemnogene Abeparvovec-xioi
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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)].

Regulatory & Marketing

Labeler Name
Novartis Gene Therapies, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125694
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-24-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71894-151-13 identifies a specific commercial package of 1 kit in 1 carton * 8.3 ml in 1 vial (71894-115-01) * 1 ml in 1 pouch * 5.5 ml in 1 vial (71894-110-01) of Zolgensma, a human prescription drug labeled by Novartis Gene Therapies, Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Gene Therapies, Inc. on May 24, 2019. The current certification is valid through December 31, 2026.

How is this Novartis Gene Therapies, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71894015113. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71894-151-13
11-Digit CMS (5-4-2)
71894-0151-13

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.