Filkri Injection, Solution
NDC Package 69448-008-63

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

Package Information

Filkri (filgrastim-laha) 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 Accord Biopharma Inc.,, this product is identified by NDC 69448-008 and is authorized under FDA application BLA761027.

Identification & Billing

NDC Package Code
69448-008-63
Package Description
1 SYRINGE in 1 BOX / .5 mL in 1 SYRINGE
Product Code
69448-008
11-Digit Billing Format
69448000863

Clinical Specifications

Proprietary Name
Filkri
Non-Proprietary Name
Filgrastim-laha
Substance Name
Filgrastim
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
FILGRASTIM 300 ug/.5mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Accord Biopharma Inc.,
Product Type
Human Prescription Drug
FDA Application #
BLA761027
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-29-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69448-008-63 identifies a specific commercial package of 1 syringe in 1 box / .5 ml in 1 syringe of Filkri, a human prescription drug labeled by Accord Biopharma 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 Accord Biopharma Inc., on June 29, 2026. 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 Accord Biopharma Inc., product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69448000863. 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)
69448-008-63
11-Digit CMS (5-4-2)
69448-0008-63

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