Mitoxantrone Injection, Solution, Concentrate
NDC Package 71288-178-10

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

Mitoxantrone injection is uSP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Meitheal Pharmaceuticals Inc., this product is identified by NDC 71288-178 and is authorized under FDA application ANDA077356.

Identification & Billing

NDC Package Code
71288-178-10
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
71288-178
11-Digit Billing Format
71288017810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 197989 - mitoXANTRONE 2 MG/ML Injectable Solution
  • RxCUI: 197989 - mitoxantrone 2 MG/ML Injectable Solution
  • RxCUI: 197989 - mitoxantrone (as mitoxantrone hydrochloride) 2 MG/ML Injectable Solution
  • RxCUI: 197989 - mitoxantrone 20 MG per 10 ML Injectable Solution
  • RxCUI: 197989 - mitoxantrone 25 MG per 12.5 ML Injectable Solution

Clinical Specifications

Proprietary Name
Mitoxantrone
Non-Proprietary Name
Mitoxantrone
Substance Name
Mitoxantrone Hydrochloride
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)
MITOXANTRONE HYDROCHLORIDE 2 mg/mL
Pharmacologic Class
Usage Information
Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone injection, USP (concentrate) is not indicated in the treatment of patients with primary progressive multiple sclerosis.The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.Mitoxantrone injection, USP (concentrate) in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.Mitoxantrone injection, USP (concentrate) in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.

Regulatory & Marketing

Labeler Name
Meitheal Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077356
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2025
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.

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.

J9293
Source: ASP
Mitoxantrone hydrochl / 5 mg
HCPCS Dosage 5 MG
Units / Pkg 4

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 71288-178-10 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose of Mitoxantrone, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. This injection, solution, concentrate is formulated for intravenous use and contains mitoxantrone hydrochloride 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 Meitheal Pharmaceuticals Inc. on June 01, 2025. The current certification is valid through December 31, 2026.

How is this Meitheal Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288017810. 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 (5-3-2)
71288-178-10
11-Digit CMS (5-4-2)
71288-0178-10

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