FDA.reportPublic FDA data

TECELRA

Product NDC
83205-0001
11-digit product format
832050001
Labeler code
83205
Product ID
83205-0001_28fa3284-38e4-4fdf-8991-2b52fe3f19fc
Type
CELLULAR THERAPY
Nonproprietary name
afamitresgene autoleucel
Dosage form
INJECTION, SUSPENSION
Route
INTRAVENOUS
Labeler
USWM, LLC
Application
BLA125789
Marketing category
BLA
Marketing start
2024-08-02
Substance
AFAMITRESGENE AUTOLEUCEL
Active strength
10000000000 1/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TECELRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AFAMITRESGENE AUTOLEUCEL10000000000 1/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CUY18BJ7BPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2690269Internal RxNorm lookup
2690275Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab24631f-3364-46e1-8074-7244863bcbabAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83205-0001-2TECELRA1 in 1 BAGINJECTION, SUSPENSION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83205-0001-2EA - Each83205-00010ebf32de-e6c5-4f51-8786-c5722764d86312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83205-0001TECELRA (AFAMITRESGENE AUTOLEUCEL) INJECTION, SUSPENSION [ADAPTIMMUNE LLC]1Current NDC, 1 package rows20240809_ab24631f-3364-46e1-8074-7244863bcbab.zip

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
ndc (product): 83205-0001

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 InjectionPSNab24631f-3364-46e1-8074-7244863bcbab13
2690275Tecelra 10,000,000,000 CELLS in 250 ML InjectionPSNab24631f-3364-46e1-8074-7244863bcbab13
2690275250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [Tecelra]SBDab24631f-3364-46e1-8074-7244863bcbab13
2690269250 ML afamitresgene autoleucel 40000000 CELLS/ML InjectionSCDab24631f-3364-46e1-8074-7244863bcbab13
2690269afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML InjectionSYab24631f-3364-46e1-8074-7244863bcbab13
2690275Tecelra 10,000,000,000 CELLS per 250 ML InjectionSYab24631f-3364-46e1-8074-7244863bcbab13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83205-0001-2832050001021 INJECTION, SUSPENSION in 1 BAG (83205-0001-2) 2024-08-02NoNoCurrent