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 Identifiers#

Field, Values table
FieldValues
UniiZ20OC92TDI
Rxcui2698206, 2698212

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

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