Ziextenzo Injection
NDC Package 61314-866-01

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

Package Information

Ziextenzo (pegfilgrastim-bmez) injection is pegfilgrastim is a man-made version of a certain natural substance made in your body. This formulation utilizes a injection delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-866 and is authorized under FDA application BLA761045.

Identification & Billing

NDC Package Code
61314-866-01
Package Description
1 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
Product Code
61314-866
11-Digit Billing Format
61314086601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ziextenzo
Non-Proprietary Name
Pegfilgrastim-bmez
Substance Name
Pegfilgrastim
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PEGFILGRASTIM 6 mg/.6mL
Pharmacologic Class
Usage Information
Pegfilgrastim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation. This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-cbqv, pegfilgrastim-jmdb, and pegfilgrastim-bmez.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761045
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-04-2019
Listing Expiration
12-31-2027
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.

Q5120
Source: ASP
Inj pegfilgrastim-bmez 0.5mg
HCPCS Dosage 0.5 MG
Units / Pkg 12

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61314-866). Click a package code to view its specific billing and regulatory data.

61314-866-02
1 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE

* 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 61314-866-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 syringe in 1 blister pack / .6 ml in 1 syringe of Ziextenzo, a human prescription drug labeled by Sandoz Inc. This injection is formulated for subcutaneous use and contains pegfilgrastim 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 Sandoz Inc on November 04, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Pegfilgrastim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation. This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-cbqv, pegfilgrastim-jmdb, and pegfilgrastim-bmez.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314086601. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
61314-866-01
11-Digit CMS (5-4-2)
61314-0866-01

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