Cyclophosphamide Injection
NDC Package 55150-271-01

11-digit billing NDC: 55150027101 · Billing unit: ML · 5 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Cyclophosphamide injection is malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with:malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphomamultiple myelomaleukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)mycosis fungoides (advanced disease)neuroblastoma (disseminated disease)adenocarcinoma of the ovaryretinoblastomacarcinoma of the breastCyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. This formulation utilizes a injection delivery system. Marketed by Eugia Us Llc, this product is identified by NDC 55150-271 and is authorized under FDA application NDA210735.

Identification & Billing

NDC Package Code
55150-271-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
55150-271
11-Digit Billing Format
55150027101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyclophosphamide
Non-Proprietary Name
Cyclophosphamide
Substance Name
Cyclophosphamide
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CYCLOPHOSPHAMIDE 1 g/5mL
Usage Information
Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with:malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphomamultiple myelomaleukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)mycosis fungoides (advanced disease)neuroblastoma (disseminated disease)adenocarcinoma of the ovaryretinoblastomacarcinoma of the breastCyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.

Regulatory & Marketing

Labeler Name
Eugia Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210735
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-25-2021
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.

J9070
Source: PDAC
CYCLOPHOSPHAMIDE, 100 MG
HCPCS Dosage 100 MG
Units / Pkg

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55150-271). Click a package code to view its specific billing and regulatory data.

55150-271-99
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE

* 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 55150-271-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Cyclophosphamide, a human prescription drug labeled by Eugia Us Llc. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This injection 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 Eugia Us Llc on August 25, 2021. The current certification is valid through December 31, 2026.

How is this Eugia Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55150027101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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)
55150-271-01
11-Digit CMS (5-4-2)
55150-0271-01

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