Voyxact Injection
NDC Package 59148-400-75

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

Package Information

Voyxact (sibeprenlimab) injection is vOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.This indication is approved under accelerated approval based on reduction of proteinuria. This formulation utilizes a injection delivery system. Marketed by Otsuka America Pharmaceutical, Inc., this product is identified by NDC 59148-400 and is authorized under FDA application BLA761434.

Identification & Billing

NDC Package Code
59148-400-75
Package Description
1 SYRINGE in 1 CARTON / 2 mL in 1 SYRINGE
Product Code
59148-400
11-Digit Billing Format
59148040075
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Voyxact
Non-Proprietary Name
Sibeprenlimab
Substance Name
Sibeprenlimab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SIBEPRENLIMAB 200 mg/mL
Usage Information
VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Regulatory & Marketing

Labeler Name
Otsuka America Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761434
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-25-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59148-400-75 identifies a specific commercial package of 1 syringe in 1 carton / 2 ml in 1 syringe of Voyxact, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. This injection is formulated for subcutaneous use and contains sibeprenlimab 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 Otsuka America Pharmaceutical, Inc. on November 25, 2025. The current certification is valid through December 31, 2027.

How is this Otsuka America Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59148040075. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
59148-400-75
11-Digit CMS (5-4-2)
59148-0400-75

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