FDA.reportPublic FDA data

TECELRA

Product NDC
87262-160
11-digit product format
872620160
Labeler code
87262
Product ID
87262-160_5eaeb5c3-0100-4714-9bc3-917f0f7538f2
Type
CELLULAR THERAPY
Nonproprietary name
afamitresgene autoleucel
Dosage form
INJECTION, SUSPENSION
Route
INTRAVENOUS
Labeler
USWM CT, LLC
Application
BLA125789
Marketing category
BLA
Marketing start
2026-01-19
Substance
AFAMITRESGENE AUTOLEUCEL
Active strength
10000000000 1/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87262-160-02TECELRA1 in 1 BAGINJECTION, SUSPENSION11

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
application number: BLA125789

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690269afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML InjectionPSN2ddd66e1-8036-4a4e-babe-4d673e660bf51
2690275Tecelra 10,000,000,000 CELLS in 250 ML InjectionPSN2ddd66e1-8036-4a4e-babe-4d673e660bf51
2690275250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [Tecelra]SBD2ddd66e1-8036-4a4e-babe-4d673e660bf51
2690269250 ML afamitresgene autoleucel 40000000 CELLS/ML InjectionSCD2ddd66e1-8036-4a4e-babe-4d673e660bf51
2690269afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML InjectionSY2ddd66e1-8036-4a4e-babe-4d673e660bf51
2690275Tecelra 10,000,000,000 CELLS per 250 ML InjectionSY2ddd66e1-8036-4a4e-babe-4d673e660bf51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87262-160-02872620160021 INJECTION, SUSPENSION in 1 BAG (87262-160-02) 2026-01-19NoNoHistorical