Ciclopirox NDC 21922-053

NDC codes

FDA NDC Directory

Product NDC (as listed)21922-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21922-0053Add 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
21922-053-51	21922005351	1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-053-51) / 6.6 mL in 1 BOTTLE, WITH APPLICATORMarketed from Nov 9, 2023

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): Ciclopirox
Generic name (nonproprietary): ciclopirox
Active ingredients: Ciclopirox — 80 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Encube Ethicals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077687
Marketing start: Nov 9, 2023
Listing expires: Dec 31, 2026
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 21922-053_c81092f6-fe1e-4f70-8699-69c4cdce214fSPL ID c81092f6-fe1e-4f70-8699-69c4cdce214fSPL set ID 79084b47-7481-4926-9837-e08f633b1ddfRxCUI 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

N421922005351 followed by a unit qualifier and the quantity

Package 21922-0053-51. 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 13, 2025.

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 the labeling.) 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 hav…

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	Preferred Pharmaceuticals Inc.	68788-8755
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	71335-2836
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	72162-2298