NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9270Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9270Add 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 NDC11-digit (billing)PackageCopy
0143-9270-0100143927001001439270011 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
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
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

N400143927001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9270

What is NDC 0143-9270?
0143-9270 is the product NDC for Floxuridine, Floxuridine 100 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA 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?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FloxuridineFloxuridine 500 mg/1Injection, Powder, Lyophilized, For solutionIntra-arterialJND Therapeutics, Inc.81643-927081643-9270-01
FloxuridineFloxuridine 500 mg/5mLInjection, Powder, Lyophilized, For solutionIntra-arterialFresenius Kabi USA, LLC63323-14563323-0145-07

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
ProductStrengthForm · routeLabelerProduct NDC
FloxuridineFloxuridine 500 mg/1Injection, Powder, Lyophilized, For solutionIntra-arterialJND Therapeutics, Inc.81643-9270

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