FDA.reportPublic FDA data

ZIIHERA

Product NDC
68727-950
11-digit product format
687270950
Labeler code
68727
Product ID
68727-950_8da60248-1456-4fa3-80d2-9c75ce77a1cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zanidatamab-hrii
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Jazz Pharmaceuticals, Inc.
Application
BLA761416
Marketing category
BLA
Marketing start
2024-11-20
Substance
ZANIDATAMAB
Active strength
50 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
ZIIHERA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZANIDATAMAB50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z20OC92TDIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2698206Internal RxNorm lookup
2698212Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae5d9425-fae5-4541-a158-150998343348Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2c3e67f-5518-4f2b-a6f6-2bbd4cb0c983Product name120250722

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68727-950-01ZIIHERA6 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,62
68727-950-02ZIIHERA2 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68727-950-01EA - Each68727-950a5fe8ad6-ad77-4ec7-a44e-7b7e6fb9f13412024-12-10
68727-950-02EA - Each68727-950b011bfd1-660f-495f-8618-3159e5f4e49612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68727-950ZIIHERA (ZANIDATAMAB-HRII) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20241123_ae5d9425-fae5-4541-a158-150998343348.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIIHERAZANIDATAMAB-HRIIJazz Pharmaceuticals, Inc.ae5d9425-fae5-4541-a158-1509983433482025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761416
ndc (product): 68727-950

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761416Ziiherazanidatamab-hrii351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2698206zanidatamab-hrii 300 MG InjectionPSNae5d9425-fae5-4541-a158-1509983433482
2698212ZIIHERA 300 MG InjectionPSNae5d9425-fae5-4541-a158-1509983433482
2698212zanidatamab-hrii 300 MG Injection [Ziihera]SBDae5d9425-fae5-4541-a158-1509983433482
2698206zanidatamab-hrii 300 MG InjectionSCDae5d9425-fae5-4541-a158-1509983433482
2698212Ziihera 300 MG InjectionSYae5d9425-fae5-4541-a158-1509983433482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68727-950-01687270950016 mL in 1 VIAL, SINGLE-DOSE6 mlHistorical
68727-950-02687270950022 VIAL, SINGLE-DOSE in 1 CARTON (68727-950-02) / 6 mL in 1 VIAL, SINGLE-DOSE (68727-950-01) 2024-11-20NoNoCurrent