Prescription drug · ANDA
Ciclopirox NDC 62135-814
Ciclopirox 71.3 mg/mL · Solution · Topical · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-814-45 | 62135081445 | 6.6 mL in 1 BOTTLE (62135-814-45)Marketed from Mar 28, 2024 |
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 — 71.3 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078046
- 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 62135-814_41b5be9e-4f27-f7aa-e063-6394a90a00d8SPL ID 41b5be9e-4f27-f7aa-e063-6394a90a00d8SPL set ID 8ce98020-5615-4332-bf57-72777e2ce038UNII 19W019ZDRJUPC 0362135814458
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
N462135081445followed by a unit qualifier and the quantityPackage 62135-0814-45. 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.