FDA.reportPublic FDA data

Zynteglo

Product NDC
73554-3111
11-digit product format
735543111
Labeler code
73554
Product ID
73554-3111_4a19a489-b94a-4a85-b094-0b6e9e3a6cd9
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125717Zynteglobetibeglogene autotemcel351(a)Rx2026-06-01

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