What is NDC 61703-343?

61703-343 is the product NDC for Mitoxantrone, Mitoxantrone hydrochloride 2 mg/mL injection, solution, concentrate, listed with the FDA by Hospira, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Hospira, Inc., NDC labeler code 61703. 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 61703-343 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61703-343Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61703-0343Add 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
61703-343-18	6170303431861703034318	1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 11, 2006
61703-343-65	6170303436561703034365	1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) / 12.5 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 11, 2006
61703-343-66	6170303436661703034366	1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) / 15 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 11, 2006

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: Hospira, Inc.NDC labeler code 61703
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076871
Marketing start: Apr 11, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 61703-343_8658f2e1-ad36-4ce0-af12-80814bd8bf5cSPL ID 8658f2e1-ad36-4ce0-af12-80814bd8bf5cSPL set ID accf9569-4b57-4e83-a7db-4e890a75d1baRxCUI 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

N461703034318 followed by a unit qualifier and the quantity

Package 61703-0343-18. 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 Jul 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Mitoxantrone 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 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 r…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61703-343

What is NDC 61703-343?: 61703-343 is the product NDC for Mitoxantrone, Mitoxantrone hydrochloride 2 mg/mL injection, solution, concentrate, listed with the FDA by Hospira, Inc.. It has 3 package NDCs, 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?: Hospira, Inc., NDC labeler code 61703. 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.	71288-178	71288-0178-10
mitoXANTRONE	Mitoxantrone hydrochloride 2 mg/mL	Injection, Solution, ConcentrateIntravenous	Meitheal Pharmaceuticals Inc.	71288-179	71288-0179-13
Mitoxantronemitoxantrone hydrochloride	Mitoxantrone hydrochloride 2 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-132	63323-0132-1063323-0132-1263323-0132-15