Fluorouracil NDC 16729-542

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-542Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0542Add 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
16729-542-35	16729054235	1 TUBE in 1 CARTON (16729-542-35) / 40 g in 1 TUBEMarketed from Nov 11, 2021

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/g
Dosage form: Cream
Route: Topical
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214845
Marketing start: Nov 11, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 16729-542_23a8557b-45e6-e3cf-e063-6394a90a4b0dSPL ID 23a8557b-45e6-e3cf-e063-6394a90a4b0dSPL set ID 667d4059-de90-4d3f-86c2-c2573def2ecbRxCUI 105583UNII U3P01618RTUPC 0316729542357
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

N416729054235 followed by a unit qualifier and the quantity

Package 16729-0542-35. 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 4, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Fluorouracil Cream USP 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 Cream…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)