Prescription drug · ANDA
Ciclopirox Olamine NDC 0713-0638
Ciclopirox olamine 7.7 mg/g · Cream · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0638-15 | 00713063815 | 1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBEMarketed from May 22, 2007 | |
| 0713-0638-18 | 00713063818 | 1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBEMarketed from May 22, 2007 | |
| 0713-0638-31 | 00713063831 | 1 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBEMarketed from May 22, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Olamine
- Generic name (nonproprietary)
- ciclopirox olamine
- Active ingredients
- Ciclopirox olamine — 7.7 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078463
- 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 0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897SPL ID ed9669ad-fa01-5788-e053-2995a90a5897SPL set ID 5c585aa5-7d2d-e798-c0bd-d602574d643cRxCUI 309289UNII 50MD4SB4APUPC 0307130638159
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
N400713063815followed by a unit qualifier and the quantityPackage 00713-0638-15. 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 Ciclopirox Olamine Cream USP, 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis ; candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur .
Excerpt only. Read the full label for complete information.