Kebilidi Suspension
NDC Package 52856-601-01

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

Package Information

Kebilidi (eladocagene exuparvovec-tneq) suspension is kEBILIDI (eladocagene exuparvovec-tneq) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. This formulation utilizes a suspension delivery system. Marketed by Ptc Therapeutics, Inc., this product is identified by NDC 52856-601 and is authorized under FDA application BLA125722.

Identification & Billing

NDC Package Code
52856-601-01
Package Description
1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS (52856-601-11)
Product Code
52856-601
11-Digit Billing Format
52856060101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Kebilidi
Non-Proprietary Name
Eladocagene Exuparvovec-tneq
Substance Name
Eladocagene Exuparvovec
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intracerebral - Administration within the cerebrum.
Active Ingredient(s)
ELADOCAGENE EXUPARVOVEC 560000000000 {GC}/mL
Usage Information
KEBILIDI (eladocagene exuparvovec-tneq) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. This indication is approved under accelerated approval based on the change from baseline in gross motor milestone achievement at 48 weeks post treatment [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Regulatory & Marketing

Labeler Name
Ptc Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125722
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-13-2024
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 52856-601-01 identifies a specific commercial package of 1 vial, glass in 1 carton / .5 ml in 1 vial, glass (52856-601-11) of Kebilidi, a human prescription drug labeled by Ptc Therapeutics, Inc.. This suspension is formulated for intracerebral use and contains eladocagene exuparvovec 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 Ptc Therapeutics, Inc. on November 13, 2024. The current certification is valid through December 31, 2027.

How is this Ptc Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52856060101. 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)
52856-601-01
11-Digit CMS (5-4-2)
52856-0601-01

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