Ciclopirox NDC 68788-8755

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8755Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8755Add 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
68788-8755-6	68788875506	1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-8755-6) / 6.6 mL in 1 BOTTLE, WITH APPLICATORMarketed from Oct 14, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Ciclopirox
Generic name (nonproprietary): ciclopirox
Active ingredients: Ciclopirox — 80 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077687
Marketing start: Oct 14, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Decreased DNA Replication (Physiologic effect)Decreased Protein Synthesis (Physiologic effect)Decreased RNA Replication (Physiologic effect)Protein Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 68788-8755_d3c4c98c-1054-4e76-b9b6-1bc37acbbc72SPL ID d3c4c98c-1054-4e76-b9b6-1bc37acbbc72SPL set ID eb7b7163-2ee7-447a-b585-7a240070f84bRxCUI 309291UNII 19W019ZDRJ

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

N468788875506 followed by a unit qualifier and the quantity

Package 68788-8755-06. 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 Jan 19, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of thelabeling.) Ciclopirox topical solution, 8% (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. • No studies ha…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077687

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

FDA NDC Directory listings under ANDA 077687
Product	Strength	Form · route	Labeler	Product NDC
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	71335-2836
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	72162-2298
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Encube Ethicals, Inc.	21922-053