Tyruko Injection
NDC Package 61314-543-94

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

Tyruko (natalizumab-sztn) injection is a medication used to treat multiple sclerosis-MS. This formulation utilizes a injection delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-543 and is authorized under FDA application BLA761322.

Identification & Billing

NDC Package Code
61314-543-94
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
Product Code
61314-543
11-Digit Billing Format
61314054394
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tyruko
Non-Proprietary Name
Natalizumab-sztn
Substance Name
Natalizumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NATALIZUMAB 300 mg/15mL
Pharmacologic Class
Usage Information
This medication is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability. Natalizumab is also used to treat a bowel condition called Crohn's disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels. Natalizumab is a protein called a monoclonal antibody.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761322
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-17-2025
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.

Q5134
Source: ASP
Inj, tyruko, 1 mg
HCPCS Dosage 1 MG
Units / Pkg 300

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 61314-543-94 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 15 ml in 1 vial, single-dose of Tyruko, a human prescription drug labeled by Sandoz Inc. This injection is formulated for intravenous use and contains natalizumab 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 Sandoz Inc on November 17, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability. Natalizumab is also used to treat a bowel condition called Crohn's disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels. Natalizumab is a protein called a monoclonal antibody.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314054394. 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)
61314-543-94
11-Digit CMS (5-4-2)
61314-0543-94

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