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

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
ndc (product): 71837-1000
BIZENGRIZENOCUTUZUMABMerus US, Inc.2a33e782-fc75-4dba-b77c-a44536ac13a52025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761352

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

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 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