FDA.reportPublic FDA data

afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection

RxCUI
2690269
RxNorm name
afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection
Display name
afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection
Full name
afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125789tecelraafamitresgene autoleucel351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TECELRAAFAMITRESGENE AUTOLEUCELUSWM CT, LLCab24631f-3364-46e1-8074-7244863bcbab2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2690269

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ab24631f-3364-46e1-8074-7244863bcbabafamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection [PSN] · 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [SCD] · afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML Injection [SY]313These highlights do not include all the information needed to use TECELRA safely and effectively. See full prescribing information for TECELRA. TECELRA ® (afamitresgene autoleucel) suspension, for intravenous infusion Initial U.S. Approval: 202420260122
2ddd66e1-8036-4a4e-babe-4d673e660bf5afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection [PSN] · 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [SCD] · afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML Injection [SY]31These highlights do not include all the information needed to use TECELRA safely and effectively. See full prescribing information for TECELRA. TECELRA ® (afamitresgene autoleucel) suspension, for intravenous infusion Initial U.S. Approval: 202420260115