Prescription drug · NDA
Naftin (naftifine hydrochloride) NDC 54766-772
Naftifine hydrochloride 2 g/100g · Gel · Topical · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54766-772-45 | 54766077245 | 1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBEMarketed from Mar 1, 2018 | |
| 54766-772-60 | 54766077260 | 1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBEMarketed from Mar 1, 2018 |
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)
- Naftin
- Generic name (nonproprietary)
- naftifine hydrochloride
- Active ingredients
- Naftifine hydrochloride — 2 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Sebela Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204286
- Marketing start
- Marketing end
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 54766-772_43150f38-df38-5e12-e063-6294a90a1128SPL ID 43150f38-df38-5e12-e063-6294a90a1128SPL set ID 6645994a-ecb3-277b-e053-2a91aa0a81e5RxCUI 1433734, 1433736UNII 25UR9N9041
- Pharmacologic class
- Allylamine Antifungal
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
N454766077245followed by a unit qualifier and the quantityPackage 54766-0772-45. 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)
NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum . NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum . ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204286
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 |
|---|---|---|---|---|
| Naftinnaftifine hydrochloride | Naftifine hydrochloride 2 g/100g | GelTopical | Legacy Pharma USA Inc. | 83107-023 |