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

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

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
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761352Bizengrizenocutuzumab-zbco351(a)Rx2026-08-01

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