Cyclophosphamide Injection, Solution, Concentrate
NDC Package 0781-3530-10

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, solution, concentrate delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-3530 and is authorized under FDA application NDA217150.

Identification & Billing

NDC Package Code
0781-3530-10
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE (0781-3530-80)
Product Code
0781-3530
11-Digit Billing Format
00781353010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2679073 - cycloPHOSphamide 100 MG/ML Injectable Solution
  • RxCUI: 2679073 - cyclophosphamide 100 MG/ML Injectable Solution
  • RxCUI: 2679073 - cyclophosphamide (as cyclophosphamide monohydrate) 100 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Cyclophosphamide
Non-Proprietary Name
Cyclophosphamide
Substance Name
Cyclophosphamide
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CYCLOPHOSPHAMIDE 2000 mg/20mL
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
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA217150
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-08-2024
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.

J9074
Source: ASP
Inj, cyclophosphamd, sandoz
HCPCS Dosage 5 MG
Units / Pkg 400

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 0781-3530-10 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose (0781-3530-80) of Cyclophosphamide, a human prescription drug labeled by Sandoz Inc. This injection, solution, concentrate 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 Sandoz Inc on April 08, 2024. The current certification is valid through December 31, 2026.

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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781353010. 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:

10-Digit Format (4-4-2)
0781-3530-10
11-Digit CMS (5-4-2)
00781-3530-10

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