Cyclophosphamide Injection, Powder, For Solution
NDC Package 10019-939-01

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

Cyclophosphamide injection is cyclophosphamide is used to treat various types of cancer. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Baxter Healthcare Company, this product is identified by NDC 10019-939 and is authorized under FDA application ANDA040745.

Identification & Billing

NDC Package Code
10019-939-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (10019-939-50)
Product Code
10019-939
11-Digit Billing Format
10019093901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyclophosphamide
Non-Proprietary Name
Cyclophosphamide
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.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CYCLOPHOSPHAMIDE 1 g/50mL
Usage Information
Cyclophosphamide is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cell growth. Cyclophosphamide also works by decreasing your immune system's response to various diseases. It is used to treat a certain type of kidney disease in children after other treatments have not worked.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Company
Product Type
Human Prescription Drug
FDA Application #
ANDA040745
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-21-2008
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.

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.

J9075
Source: ASP
Inj, cyclophosphamide, nos
HCPCS Dosage 5 MG
Units / Pkg 200

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 10019-939-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose (10019-939-50) of Cyclophosphamide, a human prescription drug labeled by Baxter Healthcare Company. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for solution is formulated for intravenous; oral 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 Baxter Healthcare Company on May 21, 2008. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Cyclophosphamide is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cell growth. Cyclophosphamide also works by decreasing your immune system's response to various diseases. It is used to treat a certain type of kidney disease in children after other treatments have not worked.

How is this Baxter Healthcare Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10019093901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
10019-939-01
11-Digit CMS (5-4-2)
10019-0939-01

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