Cyclophosphamide Injection, Powder, For Solution
NDC Package 70436-107-80

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

Package Information

Cyclophosphamide (cyclophosphamide for injection) injection is cyclophosphamide is used to treat various types of cancer. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-107 and is authorized under FDA application ANDA218632.

Identification & Billing

NDC Package Code
70436-107-80
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE
Product Code
70436-107
11-Digit Billing Format
70436010780
RxNorm Crosswalk

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
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
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218632
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-26-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70436-107-80 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 Slate Run Pharmaceuticals, Llc. 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 Slate Run Pharmaceuticals, Llc on March 26, 2025. 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 Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436010780. 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)
70436-107-80
11-Digit CMS (5-4-2)
70436-0107-80

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