FDA.reportPublic FDA data

BIZENGRI

Product NDC
71837-1000
11-digit product format
718371000
Labeler code
71837
Product ID
71837-1000_777005ee-d019-4976-abb4-b998cf68e05f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zenocutuzumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Partner Therapeutics, 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
203daea4-fc87-40a4-a92f-ba2351b16de1Available 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
71837-1000-1BIZENGRI18.75 mL in 1 VIAL, GLASSINJECTION18.753
71837-1000-2BIZENGRI2 in 1 CARTONINJECTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71837-1000-1ML - Milliliter71837-1000b45b9b5e-a879-478b-b749-377e8e2a0d6012025-01-14
71837-1000-2ML - Milliliter71837-1000af06a5e9-c393-4725-b83b-60549c57eea312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71837-1000BIZENGRI (ZENOCUTUZUMAB) INJECTION [PARTNER THERAPEUTICS, INC.]2Current NDC, 2 package rows20250309_203daea4-fc87-40a4-a92f-ba2351b16de1.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
ndc (product): 71837-1000
BIZENGRIZENOCUTUZUMABMerus US, Inc.2a33e782-fc75-4dba-b77c-a44536ac13a52025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761352

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 InjectionPSN203daea4-fc87-40a4-a92f-ba2351b16de13
2699594zenocutuzumab-zbco 375 MG in 18.75 ML InjectionPSN203daea4-fc87-40a4-a92f-ba2351b16de13
269960118.75 ML zenocutuzumab-zbco 20 MG/ML Injection [Bizengri]SBD203daea4-fc87-40a4-a92f-ba2351b16de13
269959418.75 ML zenocutuzumab-zbco 20 MG/ML InjectionSCD203daea4-fc87-40a4-a92f-ba2351b16de13
2699601Bizengri 375 MG per 18.75 ML InjectionSY203daea4-fc87-40a4-a92f-ba2351b16de13
2699594zenocutuzumab-zbco 375 MG per 18.75 ML InjectionSY203daea4-fc87-40a4-a92f-ba2351b16de13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71837-1000-17183710000118.75 mL in 1 VIAL, GLASS18.75 mlHistorical
71837-1000-2718371000022 VIAL, GLASS in 1 CARTON (71837-1000-2) / 18.75 mL in 1 VIAL, GLASS (71837-1000-1) 2024-12-16NoNoCurrent