naftin

Generic: naftifine hydrochloride

Labeler: sebela pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name naftin
Generic Name naftifine hydrochloride
Labeler sebela pharmaceuticals inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

naftifine hydrochloride 2 g/100g

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-772
Product ID 54766-772_43150f38-df38-5e12-e063-6294a90a1128
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204286
Marketing Start 2018-03-01
Marketing End 2026-10-31

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54766772
Hyphenated Format 54766-772

Supplemental Identifiers

RxCUI
1433734 1433736
UNII
25UR9N9041

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naftin (source: ndc)
Generic Name naftifine hydrochloride (source: ndc)
Application Number NDA204286 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

54766-772-45 1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE 54766-772-60 1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE

Ingredients (1)

naftifine hydrochloride (2 g/100g)

Linked Drug Pages (1)

Naftin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43150f38-df38-5e12-e063-6294a90a1128", "openfda": {"unii": ["25UR9N9041"], "rxcui": ["1433734", "1433736"], "spl_set_id": ["6645994a-ecb3-277b-e053-2a91aa0a81e5"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (54766-772-45)  / 45 g in 1 TUBE", "package_ndc": "54766-772-45", "marketing_end_date": "20261031", "marketing_start_date": "20180301"}, {"sample": false, "description": "1 TUBE in 1 CARTON (54766-772-60)  / 60 g in 1 TUBE", "package_ndc": "54766-772-60", "marketing_end_date": "20261031", "marketing_start_date": "20180301"}], "brand_name": "Naftin", "product_id": "54766-772_43150f38-df38-5e12-e063-6294a90a1128", "dosage_form": "GEL", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "54766-772", "generic_name": "Naftifine Hydrochloride", "labeler_name": "Sebela Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naftin", "active_ingredients": [{"name": "NAFTIFINE HYDROCHLORIDE", "strength": "2 g/100g"}], "application_number": "NDA204286", "marketing_category": "NDA", "marketing_end_date": "20261031", "marketing_start_date": "20180301"}