FDA.reportPublic FDA data

BIZENGRI

Product NDC
83077-100
11-digit product format
830770100
Labeler code
83077
Product ID
83077-100_0ba12e0b-78b7-4ef0-b8fd-5127f0b16581
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zenocutuzumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Merus US, Inc.
Application
BLA761352
Marketing category
BLA
Marketing start
2024-12-04
Substance
ZENOCUTUZUMAB
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIZENGRIZENOCUTUZUMABPartner Therapeutics, Inc.203daea4-fc87-40a4-a92f-ba2351b16de12026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761352
BIZENGRIZENOCUTUZUMABMerus US, Inc.2a33e782-fc75-4dba-b77c-a44536ac13a52025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761352
ndc (product): 83077-100

Additional Listing Data#

Finished product
Yes
Brand name base
BIZENGRI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZENOCUTUZUMAB20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AE72RB1W1XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2699594Internal RxNorm lookup
2699601Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a33e782-fc75-4dba-b77c-a44536ac13a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83077-100-01BIZENGRI18.75 mL in 1 VIAL, GLASSINJECTION18.752
83077-100-02BIZENGRI2 in 1 CARTONINJECTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83077-100BIZENGRI (ZENOCUTUZUMAB) INJECTION [MERUS US, INC.]2Current NDC, 2 package rows20250123_2a33e782-fc75-4dba-b77c-a44536ac13a5.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761352Bizengrizenocutuzumab-zbco351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2699601Bizengri 375 MG in 18.75 ML InjectionPSN2a33e782-fc75-4dba-b77c-a44536ac13a52
2699594zenocutuzumab-zbco 375 MG in 18.75 ML InjectionPSN2a33e782-fc75-4dba-b77c-a44536ac13a52
269960118.75 ML zenocutuzumab-zbco 20 MG/ML Injection [Bizengri]SBD2a33e782-fc75-4dba-b77c-a44536ac13a52
269959418.75 ML zenocutuzumab-zbco 20 MG/ML InjectionSCD2a33e782-fc75-4dba-b77c-a44536ac13a52
2699601Bizengri 375 MG per 18.75 ML InjectionSY2a33e782-fc75-4dba-b77c-a44536ac13a52
2699594zenocutuzumab-zbco 375 MG per 18.75 ML InjectionSY2a33e782-fc75-4dba-b77c-a44536ac13a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83077-100-018307701000118.75 mL in 1 VIAL, GLASS18.75 mlHistorical
83077-100-02830770100022 VIAL, GLASS in 1 CARTON (83077-100-02) / 18.75 mL in 1 VIAL, GLASS (83077-100-01) 2024-12-04NoNoCurrent