1. Home
  2. Labeler Index
  3. Jazz Pharmaceuticals, Inc.
  4. 68727-950
  5. NDC Package Code: 68727-950-02 Ziihera

NDC Package 68727-950-02 Ziihera

Zanidatamab-hrii Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Ziihera
Non-Proprietary Name:
Zanidatamab-hrii
Substance Name:
Zanidatamab
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).
11-Digit NDC Billing Format:
68727095002
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Jazz Pharmaceuticals, Inc.
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(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
ZANIDATAMAB 50 mg/mL
Sample Package:
No
FDA Application Number:
BLA761416
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
11-20-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 68727-950-02 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
68727095002J9276Inj zanidatamab-hrii, 2 mg2 MG12150300

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68727-950-02?

The NDC Packaged Code 68727-950-02 is assigned to a 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.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 68727-950 included in the NDC Directory?

Yes, Ziihera with product code 68727-950 is active and included in the NDC Directory. The product was first marketed by Jazz Pharmaceuticals, Inc. on November 20, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 68727-950-02?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 68727-950-02?

The 11-digit format is 68727095002. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-268727-950-025-4-268727-0950-02