What is NDC 63323-145?

63323-145 is the product NDC for Floxuridine, Floxuridine 500 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Floxuridine?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Floxuridine NDC 63323-145 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-145Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0145Add 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	Copy
63323-145-07	6332301450763323014507	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, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075837
Marketing start: Mar 15, 2001
Listing expires: Dec 31, 2027
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

N463323014507 followed by a unit qualifier and the quantity

Package 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 Oct 14, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 63323-145

What is NDC 63323-145?: 63323-145 is the product NDC for Floxuridine, Floxuridine 500 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Floxuridine.
What is the active ingredient?: Floxuridine.
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 Floxuridine?: 2 other product NDCs are listed under this name. See all Floxuridine 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 Floxuridine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Floxuridine	Floxuridine 500 mg/1	Injection, Powder, Lyophilized, For solutionIntra-arterial	JND Therapeutics, Inc.	81643-9270	81643-9270-01
Floxuridine	Floxuridine 100 mg/mL	Injection, Powder, Lyophilized, For solutionIntra-arterial	Hikma Pharmaceuticals USA Inc.	0143-9270	00143-9270-01