Lantidra Solution
NDC Package 73539-001-01

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

Package Information

Lantidra (donislecel) solution is lANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. This formulation utilizes a solution delivery system. Marketed by Celltrans Inc., this product is identified by NDC 73539-001 and is authorized under FDA application BLA125734.

Identification & Billing

NDC Package Code
73539-001-01
Package Description
400 mL in 1 BAG
Product Code
73539-001
11-Digit Billing Format
73539000101
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
Lantidra
Non-Proprietary Name
Donislecel
Substance Name
Donislecel
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravascular - Administration within a vessel or vessels.
Active Ingredient(s)
DONISLECEL 5000 [arb'U]/400mL
Usage Information
LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use LANTIDRA in conjunction with concomitant immunosuppression.

Regulatory & Marketing

Labeler Name
Celltrans Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125734
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-28-2023
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 73539-001-01 identifies a specific commercial package of 400 ml in 1 bag of Lantidra, a cellular therapy labeled by Celltrans Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This solution is formulated for intravascular use and contains donislecel 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 Celltrans Inc. on June 28, 2023. The current certification is valid through December 31, 2027.

How is this Celltrans Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73539000101. 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)
73539-001-01
11-Digit CMS (5-4-2)
73539-0001-01

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