Waskyra Injection
NDC Package 87668-0100-1

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

Package Information

Waskyra (etuvetidigene autotemcel) injection is wASKYRA® is indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. This formulation utilizes a injection delivery system. Marketed by Orphan Therapies Llc, this product is identified by NDC 87668-0100 and is authorized under FDA application BLA125846.

Identification & Billing

NDC Package Code
87668-0100-1
Package Description
20 mL in 1 BAG
Product Code
87668-0100
11-Digit Billing Format
87668010001

Clinical Specifications

Proprietary Name
Waskyra
Non-Proprietary Name
Etuvetidigene Autotemcel
Substance Name
Etuvetidigene Autotemcel
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)
ETUVETIDIGENE AUTOTEMCEL 1000000 U/mL
Usage Information
WASKYRA® is indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.

Regulatory & Marketing

Labeler Name
Orphan Therapies Llc
Product Type
Human Prescription Drug
FDA Application #
BLA125846
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-23-2026
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 87668-0100-1 identifies a specific commercial package of 20 ml in 1 bag of Waskyra, a human prescription drug labeled by Orphan Therapies Llc. This injection is formulated for intravenous use and contains etuvetidigene autotemcel 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 Orphan Therapies Llc on July 23, 2026. The current certification is valid through December 31, 2027.

How is this Orphan Therapies Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87668010001. 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 (5-4-1)
87668-0100-1
11-Digit CMS (5-4-2)
87668-0100-01

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