Fluorouracil NDC 0378-4791

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4791Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4791Add 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
0378-4791-06	00378479106	1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBEMarketed from Sep 19, 2013

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): Fluorouracil
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — 5 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 016831
Marketing start: Sep 19, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0378-4791_1ff72539-1af5-41bf-8720-1ba12df35abcSPL ID 1ff72539-1af5-41bf-8720-1ba12df35abcSPL set ID 744737c5-0d96-4214-82ab-6cff016b1ea0UNII 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

N400378479106 followed by a unit qualifier and the quantity

Package 00378-4791-06. 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 Jun 30, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluorouracil 5% Topical Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil…

Excerpt only. Read the full label for complete information.

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
Efudexfluorouracil	Fluorouracil 2 g/40g	CreamTopical	Bausch Health US, LLC	0187-3204