Prescription drug · UNAPPROVED DRUG OTHER
Ciclopirox NDC 42192-714
Kit · Acella Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42192-714-01 | 42192071401 | 1 KIT in 1 CARTON (42192-714-01) * 6.6 mL in 1 BOTTLE, WITH APPLICATOR * 28 mL in 1 BOTTLEMarketed from Oct 10, 2011 |
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
- Dosage form
- Kit
- Labeler
- Acella Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 42192-714_54a137bb-f8d5-ff18-e063-6394a90a634cSPL ID 54a137bb-f8d5-ff18-e063-6394a90a634cSPL set ID 2c67dd09-ab1f-4ccf-97b5-421356f64f22RxCUI 309291
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N442192071401followed by a unit qualifier and the quantityPackage 42192-0714-01. 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 entireINDICATIONS 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 have…
Excerpt only. Read the full label for complete information.