Fludarabine Phosphate Injection
NDC Package 59923-604-02

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

Package Information

Fludarabine Phosphate injection is a medication used to treat leukemia and other cancers. This formulation utilizes a injection delivery system. Marketed by Areva Pharmaceuticals, this product is identified by NDC 59923-604 and is authorized under FDA application ANDA090724.

Identification & Billing

NDC Package Code
59923-604-02
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
59923-604
11-Digit Billing Format
59923060402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fludarabine Phosphate
Non-Proprietary Name
Fludarabine Phosphate
Substance Name
Fludarabine Phosphate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FLUDARABINE PHOSPHATE 25 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Areva Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA090724
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2019
Listing Expiration
12-31-2026
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.

J9185
Source: ASP
Fludarabine phosphate inj
HCPCS Dosage 50 MG
Units / Pkg 1

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 59923-604-02 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Fludarabine Phosphate, a human prescription drug labeled by Areva Pharmaceuticals. This injection is formulated for intravenous use and contains fludarabine phosphate 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 Areva Pharmaceuticals on December 31, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.

How is this Areva Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59923060402. 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)
59923-604-02
11-Digit CMS (5-4-2)
59923-0604-02

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