Itvisma Injection, Suspension
NDC Package 71894-200-02

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

Package Information

Itvisma (onasemnogene abeparvovec-brve) injection is iTVISMA is indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene. This formulation utilizes a injection, suspension delivery system. Marketed by Novartis Innovative Technologies Inc., this product is identified by NDC 71894-200 and is authorized under FDA application BLA125856.

Identification & Billing

NDC Package Code
71894-200-02
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01)
Product Code
71894-200
11-Digit Billing Format
71894020002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Itvisma
Non-Proprietary Name
Onasemnogene Abeparvovec-brve
Substance Name
Onasemnogene Abeparvovec
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
Active Ingredient(s)
ONASEMNOGENE ABEPARVOVEC 40000000000000 [arb'U]/mL
Usage Information
ITVISMA is indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene.

Regulatory & Marketing

Labeler Name
Novartis Innovative Technologies Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125856
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-24-2025
Listing Expiration
12-31-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3405
Source: OPPS
Inj onase abepar-brve treat
HCPCS Dosage Per treatment
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 71894-200-02 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 3 ml in 1 vial, single-dose (71894-200-01) of Itvisma, a human prescription drug labeled by Novartis Innovative Technologies Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, suspension is formulated for intrathecal use and contains onasemnogene abeparvovec 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 Innovative Technologies Inc. on November 24, 2025. The current certification is valid through December 31, 2027.

How is this Novartis Innovative Technologies Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71894020002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
71894-200-02
11-Digit CMS (5-4-2)
71894-0200-02

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