Prescription drug · ANDA
Floxuridine NDC 63323-145
Floxuridine 500 mg/5mL · Injection, Powder, Lyophilized, For solution · Intra-arterial · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-145-07 | 63323014507 | 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIALMarketed from Mar 15, 2001 |
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)
- Floxuridine
- Generic name (nonproprietary)
- floxuridine
- Active ingredients
- Floxuridine — 500 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intra-arterial
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075837
- Marketing start
- Listing expires
- Other FDA classes
- Deoxyuridine (Chemical structure)
- Identifiers
- Product ID 63323-145_a329ca66-d65a-4fd0-a2d9-b8e70ce3bcf8SPL ID a329ca66-d65a-4fd0-a2d9-b8e70ce3bcf8SPL set ID c8edabc1-67cd-421b-a147-7c1f19f05b8eRxCUI 310351UNII 039LU44I5M
- Pharmacologic class
- Antimetabolite
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.
- NDC on a medical claim
N463323014507followed by a unit qualifier and the quantityPackage 63323-0145-07. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.
Excerpt only. Read the full label for complete information.