Avlayah Injection, Powder, Lyophilized, For Solution
NDC Package 84976-001-01

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

Package Information

Avlayah (tividenofusp alfa-eknm) injection is aVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Denali Therapeutics Inc., this product is identified by NDC 84976-001 and is authorized under FDA application BLA761485.

Identification & Billing

NDC Package Code
84976-001-01
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
84976-001
11-Digit Billing Format
84976000101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Avlayah
Non-Proprietary Name
Tividenofusp Alfa-eknm
Substance Name
Tividenofusp Alfa
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TIVIDENOFUSP ALFA 150 mg/5mL
Usage Information
AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).Limitations of UseAVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome.

Regulatory & Marketing

Labeler Name
Denali Therapeutics Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761485
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-06-2026
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 84976-001-01 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Avlayah, a human prescription drug labeled by Denali Therapeutics Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains tividenofusp alfa 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 Denali Therapeutics Inc. on April 06, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84976000101. 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)
84976-001-01
11-Digit CMS (5-4-2)
84976-0001-01

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