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  5. NDC Package Code: 71288-178-10 Mitoxantrone

NDC Package 71288-178-10 Mitoxantrone

Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Mitoxantrone
Non-Proprietary Name:
Mitoxantrone
Substance Name:
Mitoxantrone Hydrochloride
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.
11-Digit NDC Billing Format:
71288017810
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Meitheal Pharmaceuticals Inc.
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(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
MITOXANTRONE HYDROCHLORIDE 2 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA077356
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 71288-178-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
71288017810J9293Mitoxantrone hydrochl / 5 mg5 MG10144

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 71288-178-10?

The NDC Packaged Code 71288-178-10 is assigned to a 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.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

Is NDC 71288-178 included in the NDC Directory?

Yes, Mitoxantrone with product code 71288-178 is active and included in the NDC Directory. The product was first marketed by Meitheal Pharmaceuticals Inc. on June 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 71288-178-10?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 71288-178-10?

The 11-digit format is 71288017810. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-271288-178-105-4-271288-0178-10