Lenmeldy Suspension
NDC Package 83222-0200-1

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

Lenmeldy (atidarsagene autotemcel) suspension is lENMELDY is indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD). This formulation utilizes a suspension delivery system. Marketed by Orchard Therapeutics (europe) Ltd, this product is identified by NDC 83222-0200 and is authorized under FDA application BLA125758.

Identification & Billing

NDC Package Code
83222-0200-1
Package Description
1 SUSPENSION in 1 BAG
Product Code
83222-0200
11-Digit Billing Format
83222020001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Lenmeldy
Non-Proprietary Name
Atidarsagene Autotemcel
Substance Name
Atidarsagene Autotemcel
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ATIDARSAGENE AUTOTEMCEL 11800000 1/1
Usage Information
LENMELDY is indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).

Regulatory & Marketing

Labeler Name
Orchard Therapeutics (europe) Ltd
Product Type
Cellular Therapy
FDA Application #
BLA125758
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-26-2024
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.

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.

J3391
Source: OPPS
Inj, atidarsagene autotemcel
HCPCS Dosage Per Treatment Dose
Units / Pkg 1

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 83222-0200-1 identifies a specific commercial package of 1 suspension in 1 bag of Lenmeldy, a cellular therapy labeled by Orchard Therapeutics (europe) Ltd. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This suspension is formulated for intravenous use and contains atidarsagene 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 Orchard Therapeutics (europe) Ltd on April 26, 2024. The current certification is valid through December 31, 2027.

How is this Orchard Therapeutics (europe) Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83222020001. 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 (5-4-1)
83222-0200-1
11-Digit CMS (5-4-2)
83222-0200-01

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