Fluorouracil NDC 84549-117

NDC codes

FDA NDC Directory

Product NDC (as listed)84549-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84549-0117Add 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
84549-117-10	84549011710	10 mL in 1 VIAL, SINGLE-DOSE (84549-117-10)Marketed from Oct 10, 2025

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): Fluorouracil
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: ProPharma Distribution
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040279
Marketing start: Jan 2, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 84549-117_43057fcd-1f86-cc1a-e063-6294a90a8d24SPL ID 43057fcd-1f86-cc1a-e063-6294a90a8d24SPL set ID 43057fcd-1f87-cc1a-e063-6294a90a8d24RxCUI 1791701UNII U3P01618RT
Pharmacologic class: Nucleoside Metabolic Inhibitor

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N484549011710 followed by a unit qualifier and the quantity

Package 84549-0117-10. 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 Nov 7, 2025.

Indications (excerpt from the label)

Fluorouracil is indicated for the treatment of patients with: Adenocarcinoma of the Colon and Rectum Adenocarcinoma of the Breast Gastric Adenocarcinoma Pancreatic Adenocarcinoma Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum ( 1 ) Adenocarcinoma of the Breast ( 1 ) Gastric Adenocarcinoma ( 1 ) Pancreatic Adenocarcinoma ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040279

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

FDA NDC Directory listings under ANDA 040279
Product	Strength	Form · route	Labeler	Product NDC
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-117
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-117
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-117