Prescription drug · ANDA
Mitoxantrone (Mitoxantrone hydrochloride) NDC 63323-132
Mitoxantrone hydrochloride 2 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-132-10 | 6332301321063323013210 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 11, 2006 | |
| 63323-132-12 | 6332301321263323013212 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 11, 2006 | |
| 63323-132-15 | 6332301321563323013215 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 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 hydrochloride
- Active ingredients
- Mitoxantrone hydrochloride — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077496
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-132_0b47411d-1c42-4241-9301-4ecc3197470cSPL ID 0b47411d-1c42-4241-9301-4ecc3197470cSPL set ID fcb8ef8a-f770-4416-8fc5-fa01d98c8eeeRxCUI 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
N463323013210followed by a unit qualifier and the quantityPackage 63323-0132-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE: Mitoxantrone Injection, USP 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 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 cli…
Excerpt only. Read the full label for complete information.
About NDC 63323-132
- What is NDC 63323-132?
- 63323-132 is the product NDC for Mitoxantrone (mitoxantrone hydrochloride), Mitoxantrone hydrochloride 2 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mitoxantrone (Mitoxantrone hydrochloride).
- What is the active ingredient?
- Mitoxantrone hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.
Related NDCs: other Mitoxantrone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
| Mitoxantrone | Mitoxantrone hydrochloride 2 mg/mL | Injection, Solution, ConcentrateIntravenous | Hospira, Inc. | 61703-343 | 61703-0343-1861703-0343-6561703-0343-66 |