Efudex (fluorouracil) NDC 0187-3204

NDC codes

FDA NDC Directory

Product NDC (as listed)0187-3204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00187-3204Add 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
0187-3204-47	00187320447	1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBEMarketed from Jul 29, 1970

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): Efudex
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — 2 g/40g
Dosage form: Cream
Route: Topical
Labeler: Bausch Health US, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016831
Marketing start: Jul 29, 1970
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8SPL ID 3375c5f7-9b6f-8ca1-e063-6394a90aaff8SPL set ID 35de1c1c-bef5-46c5-b6f8-ea032147411cRxCUI 105583, 213045UNII 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400187320447 followed by a unit qualifier and the quantity

Package 00187-3204-47. 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 Apr 23, 2025.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 016831

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

FDA NDC Directory listings under NDA 016831
Product	Strength	Form · route	Labeler	Product NDC
Fluorouracil	Fluorouracil 5 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-4791