FDA.reportPublic FDA data

WASKYRA

Product NDC
87233-0100
Requested package NDC
87233-0100-1
11-digit product format
872330100
Labeler code
87233
Product ID
87233-0100_566bfade-f4bd-4d4c-892b-444ff5345285
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etuvetidigene autotemcel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fondazione Telethon ETS
Application
BLA125846
Marketing category
BLA
Marketing start
2026-07-23
Substance
ETUVETIDIGENE AUTOTEMCEL
Active strength
1000000 U/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETUVETIDIGENE AUTOTEMCEL1000000 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SMN5E7TJ9CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747661Internal RxNorm lookup
2747667Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45929c87-685d-b21c-e063-6394a90a3818Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WASKYRAETUVETIDIGENE AUTOTEMCELFondazione Telethon ETS45929c87-685d-b21c-e063-6394a90a38182026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA125846
ndc (package): 87233-0100-1
ndc (product): 87233-0100
ndc11 (package): 87233010001
WASKYRAETUVETIDIGENE AUTOTEMCELOrphan Therapies LLC106880df-7a30-4a0f-9e16-9f20fcc7d1382026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA125846

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125846waskyraetuvetidigene autotemcel351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87233-0100-18723301000120 mL in 1 BAG (87233-0100-1) 20 ml2026-07-23NoNoCurrent