Zarxio Injection, Solution
NDC Package 61314-326-63
Package Information
Zarxio (filgrastim-sndz) injection is filgrastim is a man-made version of a certain natural substance made in your body. This formulation utilizes a injection, solution delivery system. Marketed by Sandoz Inc., this product is identified by NDC 61314-326 and is authorized under FDA application BLA125553.
Identification & Billing
- RxCUI: 1605066 - filgrastim-sndz 300 MCG in 0.5 ML Prefilled Syringe
- RxCUI: 1605066 - 0.5 ML filgrastim-sndz 0.6 MG/ML Prefilled Syringe
- RxCUI: 1605066 - filgrastim-sndz 300 MCG per 0.5 ML Prefilled Syringe
- RxCUI: 1605071 - Zarxio 300 MCG in 0.5 ML Prefilled Syringe
- RxCUI: 1605071 - 0.5 ML filgrastim-sndz 0.6 MG/ML Prefilled Syringe [Zarxio]
Clinical Specifications
- Intravenous - Administration within or into a vein or veins.
- Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Regulatory & Marketing
Hierarchy Structure
- 61314 - Sandoz Inc.
- 61314-326 - Zarxio
- 61314-326-63 - 1 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .8 mL in 1 SYRINGE
- 61314-326 - Zarxio
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (61314-326). Click a package code to view its specific billing and regulatory data.
* 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 61314-326-63 identifies a specific commercial package of 1 blister pack in 1 carton / 1 syringe in 1 blister pack / .8 ml in 1 syringe of Zarxio, a human prescription drug labeled by Sandoz Inc.. This injection, solution is formulated for intravenous; subcutaneous use and contains filgrastim 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 March 06, 2015. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
Filgrastim 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. Filgrastim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy, chronic neutropenia, or exposure to large amounts of radiation). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant). This monograph is about the following filgrastim products: filgrastim, tbo-filgrastim, filgrastim-sndz, and filgrastim-aafi.
How is this Sandoz Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314032663. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
