Prescription drug · ANDA
Floxuridine NDC 0143-9270
Floxuridine 100 mg/mL · Injection, Powder, Lyophilized, For solution · Intra-arterial · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9270-01 | 00143927001 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9270-01) / 5 mL in 1 VIALMarketed from Feb 15, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intra-arterial
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075387
- Marketing start
- Listing expires
- Other FDA classes
- Deoxyuridine (Chemical structure)
- Identifiers
- Product ID 0143-9270_0ee8505b-6680-410d-94bf-d55558a8c0e8SPL ID 0ee8505b-6680-410d-94bf-d55558a8c0e8SPL set ID e3c2e3e7-bc83-465d-b615-3ad56580b3a7RxCUI 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
N400143927001followed by a unit qualifier and the quantityPackage 00143-9270-01. 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 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.
Other NDCs under ANDA 075387
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Floxuridine | Floxuridine 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntra-arterial | JND Therapeutics, Inc. | 81643-9270 |