Clofarabine Injection
NDC Package 72205-394-01

11-digit billing NDC: 72205039401 · Billing unit: ML · 20 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This formulation utilizes a injection delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-394 and is authorized under FDA application ANDA209775.

Identification & Billing

NDC Package Code
72205-394-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
72205-394
11-Digit Billing Format
72205039401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
20 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clofarabine
Non-Proprietary Name
Clofarabine
Substance Name
Clofarabine
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)
CLOFARABINE 1 mg/mL
Pharmacologic Class
Usage Information
Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209775
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2026
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 72205-394-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Clofarabine, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package. This injection is formulated for intravenous use and contains clofarabine 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 Novadoz Pharmaceuticals Llc on September 01, 2026. The current certification is valid through December 31, 2027.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205039401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 20 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)
72205-394-01
11-Digit CMS (5-4-2)
72205-0394-01

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