Prescription drug · ANDA
Mitoxantrone NDC 61703-343
Mitoxantrone hydrochloride 2 mg/mL · Injection, Solution, Concentrate · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61703-343-18 | 61703034318 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 11, 2006 | |
| 61703-343-65 | 61703034365 | 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 | 61703034366 | 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.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076871
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N461703034318followed by a unit qualifier and the quantityPackage 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 . 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.