Udenyca Injection, Solution
NDC Package 69448-025-63
Package Information
Udenyca (pegfilgrastim-cbqv) injection is pegfilgrastim 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 69448-025 and is authorized under FDA application BLA761039.
Identification & Billing
- RxCUI: 2102703 - pegfilgrastim-cbqv 6 MG in 0.6 ML Prefilled Syringe
- RxCUI: 2102703 - 0.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled Syringe
- RxCUI: 2102705 - UDENYCA 6 MG in 0.6 ML Prefilled Syringe
- RxCUI: 2102705 - 0.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled Syringe [Udenyca]
- RxCUI: 2102705 - 0.6 ML Udenyca 10 MG/ML Prefilled Syringe
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 69448 - Accord Biopharma, Inc.
- 69448-025 - Udenyca
- 69448-025-63 - 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE
- 69448-025 - Udenyca
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.
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 69448-025-63 identifies a specific commercial package of 1 syringe in 1 carton / .6 ml in 1 syringe of Udenyca, a human prescription drug labeled by Accord Biopharma, Inc.. This injection, solution 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 Accord Biopharma, Inc. on December 15, 2025. 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 Accord Biopharma, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 69448002563. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
