Fludarabine Phosphate Injection, Solution
NDC Package 42658-024-01

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

Package Information

Fludarabine Phosphate injection is a medication used to treat leukemia and other cancers. This formulation utilizes a injection, solution delivery system. Marketed by Hisun Pharmaceuticals Usa, Inc., this product is identified by NDC 42658-024 and is authorized under FDA application ANDA220196.

Identification & Billing

NDC Package Code
42658-024-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
42658-024
11-Digit Billing Format
42658002401

Clinical Specifications

Proprietary Name
Fludarabine Phosphate
Non-Proprietary Name
Fludarabine Phosphate
Substance Name
Fludarabine Phosphate
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.
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
Hisun Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA220196
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2026
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 42658-024-01 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 Hisun Pharmaceuticals Usa, Inc.. This injection, solution 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 Hisun Pharmaceuticals Usa, Inc. on September 01, 2026. The current certification is valid through December 31, 2027.

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 Hisun Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42658002401. 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)
42658-024-01
11-Digit CMS (5-4-2)
42658-0024-01

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