Aqneursa Granule, For Suspension
NDC Package 83853-101-01

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

Package Information

Aqneursa (levacetylleucine) granules is <BRAND NAME> is indicated for the chronic treatment of Niemann-Pick Type C (NPC) in adults and children aged 4 years and older. This formulation utilizes a granule, for suspension delivery system. Marketed by Intrabio Inc, this product is identified by NDC 83853-101 and is authorized under FDA application NDA219132.

Identification & Billing

NDC Package Code
83853-101-01
Package Description
28 PACKET in 1 CARTON / 1 GRANULE, FOR SUSPENSION in 1 PACKET
Product Code
83853-101
11-Digit Billing Format
83853010101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aqneursa
Non-Proprietary Name
Levacetylleucine
Substance Name
Levacetylleucine
Dosage Form
Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVACETYLLEUCINE 1000 mg/1
Pharmacologic Class
Usage Information
<BRAND NAME> is indicated for the chronic treatment of Niemann-Pick Type C (NPC) in adults and children aged 4 years and older.

Regulatory & Marketing

Labeler Name
Intrabio Inc
Product Type
Human Prescription Drug
FDA Application #
NDA219132
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-24-2024
Listing Expiration
12-31-2026
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 83853-101-01 identifies a specific commercial package of 28 packet in 1 carton / 1 granule, for suspension in 1 packet of Aqneursa, a human prescription drug labeled by Intrabio Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This granule, for suspension is formulated for oral use and contains levacetylleucine 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 Intrabio Inc on September 24, 2024. The current certification is valid through December 31, 2026.

How is this Intrabio Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83853010101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
83853-101-01
11-Digit CMS (5-4-2)
83853-0101-01

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