Rethymic Implant
NDC Package 72359-001-01

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

Package Information

Rethymic (allogenic thymocyte-depleted thymus tissue-agdc) implants is rETHYMIC® is indicated for immune reconstitution in pediatric patients with congenital athymia. This formulation utilizes a implant delivery system. Marketed by Sumitomo Pharma America, Inc., this product is identified by NDC 72359-001 and is authorized under FDA application BLA125685.

Identification & Billing

NDC Package Code
72359-001-01
Package Description
11 CONTAINER in 1 BOX / 4 IMPLANT in 1 CONTAINER (72359-001-02)
Product Code
72359-001
11-Digit Billing Format
72359000101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
11 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rethymic
Non-Proprietary Name
Allogenic Thymocyte-depleted Thymus Tissue-agdc
Substance Name
Allogeneic Thymocyte-depleted Thymus Tissue-agdc
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC 22000 mm/1
Usage Information
RETHYMIC® is indicated for immune reconstitution in pediatric patients with congenital athymia.

Regulatory & Marketing

Labeler Name
Sumitomo Pharma America, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125685
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-08-2021
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 72359-001-01 identifies a specific commercial package of 11 container in 1 box / 4 implant in 1 container (72359-001-02) of Rethymic, a human prescription drug labeled by Sumitomo Pharma America, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 11 billable units per package. This implant is formulated for intramuscular use and contains allogeneic thymocyte-depleted thymus tissue-agdc 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 Sumitomo Pharma America, Inc. on October 08, 2021. The current certification is valid through December 31, 2026.

How is this Sumitomo Pharma America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72359000101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 11 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)
72359-001-01
11-Digit CMS (5-4-2)
72359-0001-01

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