NDC 83205-0001-02 - TECELRA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 83205-0001
Requested NDC: 83205-0001-02
Package NDCs from labels: 83205-0001-2, 83205-0001-02
Manufacturer: USWM CT, LLC
Effective date: 2026-07-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
TECELRA - USWM CT, LLC	USWM CT, LLC	2026-07-15	CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83205-0001-2	TECELRA	1 in 1 BAG	INJECTION, SUSPENSION	1		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83205-0001	TECELRA (AFAMITRESGENE AUTOLEUCEL) INJECTION, SUSPENSION [ADAPTIMMUNE LLC]	1	Current NDC, 1 package rows	20240809_ab24631f-3364-46e1-8074-7244863bcbab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83205-0001-2	EA - Each	83205-0001	0ebf32de-e6c5-4f51-8786-c5722764d863	1	2024-08-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimethyl Sulfoxide	DIMETHYL SULFOXIDE	Renova Pharmaceuticals LLC	8f699de6-9d09-48da-9d95-4001d7008587	2026-07-20	Warnings, Adverse reactions	Exact identifier unii: YOW8V9698H
TECELRA	AFAMITRESGENE AUTOLEUCEL	USWM CT, LLC	ab24631f-3364-46e1-8074-7244863bcbab	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125789 ndc (package): 83205-0001-2 ndc (product): 83205-0001 ndc11 (package): 83205000102 rxcui: 2690269 rxcui: 2690275 spl id: bc55f8cd-4e1e-45a5-8be2-d6633ed7a7f1 spl set id: ab24631f-3364-46e1-8074-7244863bcbab unii: CUY18BJ7BP
RIMSO-50	DIMETHYL SULFOXIDE	Mylan Institutional LLC	58b25d79-78f2-4953-b0c6-61658dc4ef0d	2021-03-17	Warnings, Adverse reactions	Exact identifier unii: YOW8V9698H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.