ziihera

Generic: zanidatamab-hrii

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ziihera
Generic Name zanidatamab-hrii
Labeler jazz pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

zanidatamab 50 mg/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-950
Product ID 68727-950_8da60248-1456-4fa3-80d2-9c75ce77a1cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761416
Listing Expiration 2026-12-31
Marketing Start 2024-11-20

Pharmacologic Class

Established (EPC)
bispecific her2-directed antibody [epc]
Mechanism of Action
her2-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727950
Hyphenated Format 68727-950

Supplemental Identifiers

RxCUI
2698206 2698212
UNII
Z20OC92TDI
NUI
N0000194137 N0000194138

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ziihera (source: ndc)
Generic Name zanidatamab-hrii (source: ndc)
Application Number BLA761416 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (68727-950-02) / 6 mL in 1 VIAL, SINGLE-DOSE (68727-950-01)
source: ndc

Packages (1)

68727-950-02 2 VIAL, SINGLE-DOSE in 1 CARTON (68727-950-02) / 6 mL in 1 VIAL, SINGLE-DOSE (68727-950-01)

Ingredients (1)

zanidatamab (50 mg/mL)

Linked Drug Pages (1)

ZIIHERA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8da60248-1456-4fa3-80d2-9c75ce77a1cf", "openfda": {"nui": ["N0000194137", "N0000194138"], "unii": ["Z20OC92TDI"], "rxcui": ["2698206", "2698212"], "spl_set_id": ["ae5d9425-fae5-4541-a158-150998343348"], "pharm_class_epc": ["Bispecific HER2-directed Antibody [EPC]"], "pharm_class_moa": ["HER2-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (68727-950-02)  / 6 mL in 1 VIAL, SINGLE-DOSE (68727-950-01)", "package_ndc": "68727-950-02", "marketing_start_date": "20241120"}], "brand_name": "ZIIHERA", "product_id": "68727-950_8da60248-1456-4fa3-80d2-9c75ce77a1cf", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "68727-950", "generic_name": "zanidatamab-hrii", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZIIHERA", "active_ingredients": [{"name": "ZANIDATAMAB", "strength": "50 mg/mL"}], "application_number": "BLA761416", "marketing_category": "BLA", "marketing_start_date": "20241120", "listing_expiration_date": "20261231"}