Prescription drug · NDA
Naftin (Naftifine hydrochloride) NDC 83107-023
Naftifine hydrochloride 2 g/100g · Gel · Topical · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-023-45 | 8310700234583107002345 | 1 TUBE in 1 CARTON (83107-023-45) / 45 g in 1 TUBEMarketed from Jul 29, 2025 | |
| 83107-023-60 | 8310700236083107002360 | 1 TUBE in 1 CARTON (83107-023-60) / 60 g in 1 TUBEMarketed from Jul 29, 2025 |
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
- Legacy Pharma USA Inc.NDC labeler code 83107
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204286
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 83107-023_3b299c91-fdf6-726c-e063-6394a90ad77bSPL ID 3b299c91-fdf6-726c-e063-6394a90ad77bSPL set ID 6c6ee055-4031-45a7-8561-ccd989343580RxCUI 1433734, 1433736UNII 25UR9N9041UPC 0383107023609
- 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
N483107002345followed by a unit qualifier and the quantityPackage 83107-0023-45. 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.
About NDC 83107-023
- What is NDC 83107-023?
- 83107-023 is the product NDC for Naftin (naftifine hydrochloride), Naftifine hydrochloride 2 g/100g gel, listed with the FDA by Legacy Pharma USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naftin (Naftifine Hydrochloride).
- What is the active ingredient?
- Naftifine hydrochloride.
- Who is the labeler?
- Legacy Pharma USA Inc., NDC labeler code 83107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naftin?
- 1 other product NDC are listed under this name. See all Naftin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naftin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naftinnaftifine hydrochloride | Naftifine hydrochloride 2 g/100g | GelTopical | Sebela Pharmaceuticals Inc. | 54766-772 | 54766-0772-4554766-0772-60 |
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 | Sebela Pharmaceuticals Inc. | 54766-772 |