Drug
Who makes naftifine hydrochloride?
3 companies list naftifine hydrochloride as a human prescription drug, including under the names Naftin. Forms: cream; gel. Routes: topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing naftifine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | cream; gel | ANDAANDA205975, ANDA206901, ANDA208201 | 3 | 13 |
| Legacy Pharma USA Inc.United States | gel | NDANDA204286 | 1 | 1 |
| Sebela Pharmaceuticals Inc. | gel | NDANDA204286 | 1 | 0 |
Bulk ingredient listings
- Erregierre SpAItaly · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Olon USA LLCItaly · 1 NDC
Orange Book patents
6 unexpired patents list naftifine hydrochloride as the active ingredient, expiring between Jan 2033 and Jan 2033. Application holder: LEGACY PHARMA INC SEZC.
Enquiry
Common questions
- Who makes naftifine hydrochloride?
- 3 companies list naftifine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Legacy Pharma USA Inc., Sebela Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Naftin?
- 1 company lists naftifine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies naftifine hydrochloride active ingredient?
- 3 companies list naftifine hydrochloride as a bulk ingredient, including Erregierre SpA, MSN Laboratories Private Limited,, Olon USA LLC.