Tecelra Injection, Suspension
NDC Package 83205-0001-2

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

Tecelra (afamitresgene autoleucel) injection is tECELRA is a melanoma-associated antigen A4-(MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies (14)]. This formulation utilizes a injection, suspension delivery system. Marketed by Uswm, Llc, this product is identified by NDC 83205-0001 and is authorized under FDA application BLA125789.

Identification & Billing

NDC Package Code
83205-0001-2
Package Description
1 INJECTION, SUSPENSION in 1 BAG
Product Code
83205-0001
11-Digit Billing Format
83205000102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2690269 - afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection
  • RxCUI: 2690269 - 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection
  • RxCUI: 2690269 - afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML Injection
  • RxCUI: 2690275 - Tecelra 10,000,000,000 CELLS in 250 ML Injection
  • RxCUI: 2690275 - 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [Tecelra]

Clinical Specifications

Proprietary Name
Tecelra
Non-Proprietary Name
Afamitresgene Autoleucel
Substance Name
Afamitresgene Autoleucel
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AFAMITRESGENE AUTOLEUCEL 10000000000 1/1
Usage Information
TECELRA is a melanoma-associated antigen A4-(MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Uswm, Llc
Product Type
Cellular Therapy
FDA Application #
BLA125789
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-02-2024
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.

Q2057
Source: ASP
Afamitresgene autoleucel
HCPCS Dosage Per Therapeutic 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 83205-0001-2 identifies a specific commercial package of 1 injection, suspension in 1 bag of Tecelra, a cellular therapy labeled by Uswm, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, suspension is formulated for intravenous use and contains afamitresgene autoleucel 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 Uswm, Llc on August 02, 2024. The current certification is valid through December 31, 2027.

How is this Uswm, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83205000102. 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)
83205-0001-2
11-Digit CMS (5-4-2)
83205-0001-02

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