Prescription drug · ANDA
Naftifine Hydrochloride NDC 51672-1362
Naftifine hydrochloride 10 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1362-1 | 51672136201 | 1 TUBE in 1 CARTON (51672-1362-1) / 15 g in 1 TUBEMarketed from Sep 8, 2016 | |
| 51672-1362-2 | 51672136202 | 1 TUBE in 1 CARTON (51672-1362-2) / 30 g in 1 TUBEMarketed from Sep 8, 2016 | |
| 51672-1362-3 | 51672136203 | 1 TUBE in 1 CARTON (51672-1362-3) / 60 g in 1 TUBEMarketed from Sep 8, 2016 | |
| 51672-1362-8 | 51672136208 | 1 TUBE in 1 CARTON (51672-1362-8) / 90 g in 1 TUBEMarketed from Sep 8, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Naftifine Hydrochloride
- Generic name (nonproprietary)
- naftifine hydrochloride
- Active ingredients
- Naftifine hydrochloride — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205975
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 51672-1362_39620da3-e660-e94f-e063-6294a90afd69SPL ID 39620da3-e660-e94f-e063-6294a90afd69SPL set ID d50961c2-e97f-4583-91d6-7cafd25a8c3dRxCUI 896110UNII 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
N451672136201followed by a unit qualifier and the quantityPackage 51672-1362-01. 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 Naftifine Hydrochloride Cream USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .
Excerpt only. Read the full label for complete information.
About NDC 51672-1362
- What is NDC 51672-1362?
- 51672-1362 is the product NDC for Naftifine Hydrochloride, Naftifine hydrochloride 10 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naftifine Hydrochloride.
- What is the active ingredient?
- Naftifine hydrochloride.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naftifine Hydrochloride?
- 2 other product NDCs are listed under this name. See all Naftifine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naftifine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naftifine Hydrochloride | Naftifine hydrochloride 20 mg/g | GelTopical | Sun Pharmaceutical Industries, Inc. | 51672-1376 | 51672-1376-0351672-1376-06 |
| Naftifine Hydrochloride | Naftifine hydrochloride 20 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1368 | 51672-1368-0251672-1368-0351672-1368-06 |