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  5. NDC Package Code: 83205-0001-2 Tecelra

NDC Package 83205-0001-2 Tecelra

Afamitresgene Autoleucel Injection, Suspension Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83205-0001-2
Package Description:
1 INJECTION, SUSPENSION in 1 BAG
Product Code:
83205-0001
Proprietary Name:
Tecelra
Non-Proprietary Name:
Afamitresgene Autoleucel
Substance Name:
Afamitresgene Autoleucel
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.
11-Digit NDC Billing Format:
83205000102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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]
Product Type:
Cellular Therapy
Labeler Name:
Adaptimmune Llc
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(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
AFAMITRESGENE AUTOLEUCEL 10000000000 1/1
Sample Package:
No
FDA Application Number:
BLA125789
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
08-02-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 83205-0001-2 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
83205000102Q2057Afamitresgene autoleucelPer Therapeutic Dose1111

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 83205-0001-2?

The NDC Packaged Code 83205-0001-2 is assigned to a package of 1 injection, suspension in 1 bag of Tecelra, a cellular therapy labeled by Adaptimmune Llc. The product's dosage form is injection, suspension and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 83205-0001 included in the NDC Directory?

Yes, Tecelra with product code 83205-0001 is active and included in the NDC Directory. The product was first marketed by Adaptimmune Llc on August 02, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 83205-0001-2?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 83205-0001-2?

The 11-digit format is 83205000102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-183205-0001-25-4-283205-0001-02