What is NDC 81643-9270?

81643-9270 is the product NDC for Floxuridine, Floxuridine 500 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by JND Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

JND Therapeutics, Inc., NDC labeler code 81643. 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 81643-9270 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81643-9270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81643-9270Add 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
81643-9270-1	8164392700181643927001	1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jun 9, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intra-arterial
Labeler: JND Therapeutics, Inc.NDC labeler code 81643
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075387
Marketing start: Jun 9, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Deoxyuridine (Chemical structure)
Identifiers: Product ID 81643-9270_42039e70-fc10-450f-9dec-2b0402160bdaSPL ID 42039e70-fc10-450f-9dec-2b0402160bdaSPL set ID 4681f23e-6b5e-433b-b245-3d0b4e64ebb2RxCUI 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

N481643927001 followed by a unit qualifier and the quantity

Package 81643-9270-01. 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 Oct 7, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 81643-9270

What is NDC 81643-9270?: 81643-9270 is the product NDC for Floxuridine, Floxuridine 500 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by JND Therapeutics, Inc.. 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?: JND Therapeutics, Inc., NDC labeler code 81643. 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 100 mg/mL	Injection, Powder, Lyophilized, For solutionIntra-arterial	Hikma Pharmaceuticals USA Inc.	0143-9270	00143-9270-01
Floxuridine	Floxuridine 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntra-arterial	Fresenius Kabi USA, LLC	63323-145	63323-0145-07

Other NDCs under ANDA 075387

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075387
Product	Strength	Form · route	Labeler	Product NDC
Floxuridine	Floxuridine 100 mg/mL	Injection, Powder, Lyophilized, For solutionIntra-arterial	Hikma Pharmaceuticals USA Inc.	0143-9270