Prescription drug · ANDA
Ciclopirox NDC 71335-2836
Ciclopirox 80 mg/mL · Solution · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2836-1 | 71335283601 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (71335-2836-1) / 6.6 mL in 1 BOTTLE, WITH APPLICATORMarketed from Oct 22, 2025 |
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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077687
- Marketing start
- Listing expires
- 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 71335-2836_aa26cf31-7dfe-4454-9d18-53ecd28dbc15SPL ID aa26cf31-7dfe-4454-9d18-53ecd28dbc15SPL set ID 1548af93-0dc1-4606-865f-6201b2bb7de1RxCUI 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
N471335283601followed by a unit qualifier and the quantityPackage 71335-2836-01. 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 .
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.
Other NDCs under ANDA 077687
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | 72162-2298 |
| Ciclopirox | Ciclopirox 80 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-053 |