What is NDC 71288-178?

71288-178 is the product NDC for mitoXANTRONE, Mitoxantrone hydrochloride 2 mg/mL injection, solution, concentrate, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for mitoXANTRONE?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

mitoXANTRONE NDC 71288-178 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-178Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0178Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71288-178-10	7128801781071288017810	1 VIAL, MULTI-DOSE in 1 CARTON (71288-178-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 1, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): mitoXANTRONE
Generic name (nonproprietary): mitoxantrone
Active ingredients: Mitoxantrone hydrochloride — 2 mg/mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077356
Marketing start: Jun 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 71288-178_37d2fbfc-59e6-437f-90d2-cab7b7d099f1SPL ID 37d2fbfc-59e6-437f-90d2-cab7b7d099f1SPL set ID 1634528a-30c5-4309-acc8-4c0293ae14aeRxCUI 197989UNII U6USW86RD0
Pharmacologic class: Topoisomerase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N471288017810 followed by a unit qualifier and the quantity

Package 71288-0178-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71288-178

What is NDC 71288-178?: 71288-178 is the product NDC for mitoXANTRONE, Mitoxantrone hydrochloride 2 mg/mL injection, solution, concentrate, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: mitoXANTRONE.
What is the active ingredient?: Mitoxantrone hydrochloride.
Who is the labeler?: Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for mitoXANTRONE?: 3 other product NDCs are listed under this name. See all mitoXANTRONE NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other mitoXANTRONE NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
mitoXANTRONE	Mitoxantrone hydrochloride 2 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-179	71288-0179-13
Mitoxantrone	Mitoxantrone hydrochloride 2 mg/mL	Injection, Solution, ConcentrateIntravenous	Hospira, Inc.	61703-343	61703-0343-1861703-0343-6561703-0343-66
Mitoxantronemitoxantrone hydrochloride	Mitoxantrone hydrochloride 2 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-132	63323-0132-1063323-0132-1263323-0132-15

Other NDCs under ANDA 077356

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077356
Product	Strength	Form · route	Labeler	Product NDC
mitoXANTRONE	Mitoxantrone hydrochloride 2 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-179