Cyclophosphamide Injection, Powder, For Solution
NDC Package 42658-034-01

11-digit billing NDC: 42658003401
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cyclophosphamide (cyclophosphamide for injection) injection is •HypersensitivityCyclophosphamide for Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to cyclophosphamide, any of its metabolites, or to other components of the product. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Hisun Pharmaceuticals Usa, Inc., this product is identified by NDC 42658-034 and is authorized under FDA application ANDA218632.

Identification & Billing

NDC Package Code
42658-034-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE
Product Code
42658-034
11-Digit Billing Format
42658003401

Clinical Specifications

Proprietary Name
Cyclophosphamide
Non-Proprietary Name
Cyclophosphamide For Injection
Substance Name
Cyclophosphamide
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CYCLOPHOSPHAMIDE 2 g/100mL
Usage Information
•HypersensitivityCyclophosphamide for Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to cyclophosphamide, any of its metabolites, or to other components of the product. Anaphylactic reactions including death have been reported with cyclophosphamide. Cross-sensitivity with other alkylating agents can occur.•Urinary Outflow ObstructionCyclophosphamide Injection is contraindicated in patients with urinary outflow obstruction [see Warnings and Precautions ( 5.2)].

Regulatory & Marketing

Labeler Name
Hisun Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218632
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-2026
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 42658-034-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 100 ml in 1 vial, single-dose of Cyclophosphamide, a human prescription drug labeled by Hisun Pharmaceuticals Usa, Inc.. This injection, powder, for solution is formulated for intravenous use and contains cyclophosphamide 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 October 16, 2026. The current certification is valid through December 31, 2027.

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: 42658003401. 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)
42658-034-01
11-Digit CMS (5-4-2)
42658-0034-01

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