Ziihera Injection, Powder, Lyophilized, For Solution
NDC Package 68727-950-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Ziihera (zanidatamab-hrii) injection is zIIHERA is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test [see Dosage and Administration (2.1)].This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 68727-950 and is authorized under FDA application BLA761416.

Identification & Billing

NDC Package Code
68727-950-02
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE (68727-950-01)
Product Code
68727-950
11-Digit Billing Format
68727095002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziihera
Non-Proprietary Name
Zanidatamab-hrii
Substance Name
Zanidatamab
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ZANIDATAMAB 50 mg/mL
Usage Information
ZIIHERA is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test [see Dosage and Administration (2.1)].This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Jazz Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761416
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-20-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9276
Source: ASP
Inj zanidatamab-hrii, 2 mg
HCPCS Dosage 2 MG
Units / Pkg 300

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68727-950-02 identifies a specific commercial package of 2 vial, single-dose in 1 carton / 6 ml in 1 vial, single-dose (68727-950-01) of Ziihera, a human prescription drug labeled by Jazz Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains zanidatamab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Jazz Pharmaceuticals, Inc. on November 20, 2024. The current certification is valid through December 31, 2026.

How is this Jazz Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68727095002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68727-950-02
11-Digit CMS (5-4-2)
68727-0950-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.