FDA.reportPublic FDA data

Zynteglo

Product NDC
73554-3111
11-digit product format
735543111
Labeler code
73554
Product ID
73554-3111_ad3b5513-b7ff-492d-ad78-ea5a4bd44510
Type
CELLULAR THERAPY
Nonproprietary name
betibeglogene autotemcel
Dosage form
SUSPENSION
Route
INTRAVENOUS
Labeler
Genetix Biotherapeutics Inc.
Application
BLA125717
Marketing category
BLA
Marketing start
2022-08-17
Substance
BETIBEGLOGENE AUTOTEMCEL
Active strength
20000000 1/1
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
Zynteglo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETIBEGLOGENE AUTOTEMCEL20000000 1/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MEE8487RTPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610435Internal RxNorm lookup
2610436Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
86931613-c262-47f5-8202-bc31fa69ad3dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73554-3111-1Zynteglo1 in 1 BAGSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73554-3111-1EA - Each73554-31111a10af94-9605-40ae-af54-7f7ab70134ec12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73554-3111ZYNTEGLO (BETIBEGLOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.]4Current NDC, Legacy NDC, 1 package rows20231207_86931613-c262-47f5-8202-bc31fa69ad3d.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
ZyntegloBETIBEGLOGENE AUTOTEMCELGenetix Biotherapeutics Inc.86931613-c262-47f5-8202-bc31fa69ad3d2026-07-21Warnings, Adverse reactionsExact identifier
application number: BLA125717
ndc (product): 73554-3111

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125717Zynteglobetibeglogene autotemcel351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610435betibeglogene autotemcel 20 ML InjectionPSN86931613-c262-47f5-8202-bc31fa69ad3d6
2610436zynteglo 20 ML InjectionPSN86931613-c262-47f5-8202-bc31fa69ad3d6
261043620 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]SBD86931613-c262-47f5-8202-bc31fa69ad3d6
261043520 ML betibeglogene autotemcel 20000000 CELLS/ML InjectionSCD86931613-c262-47f5-8202-bc31fa69ad3d6
261043620 ML Zynteglo 20000000 CELLS/ML InjectionSY86931613-c262-47f5-8202-bc31fa69ad3d6
2610435betibeglogene autotemcel 20 ML InjectionSY86931613-c262-47f5-8202-bc31fa69ad3d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73554-3111-1735543111011 SUSPENSION in 1 BAG (73554-3111-1) 1 suspension2022-08-170000-00-00NoNoCurrent