naftifine hydrochloride

Generic: naftifine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naftifine hydrochloride
Generic Name naftifine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

naftifine hydrochloride 20 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1376
Product ID 51672-1376_4aa35016-7749-87c7-e063-6394a90ac5c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208201
Listing Expiration 2027-12-31
Marketing Start 2023-04-01

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721376
Hyphenated Format 51672-1376

Supplemental Identifiers

RxCUI
1433734
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 naftifine hydrochloride (source: ndc)
Generic Name naftifine hydrochloride (source: ndc)
Application Number ANDA208201 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1376-3) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1376-6) / 45 g in 1 TUBE
source: ndc

Packages (2)

51672-1376-3 1 TUBE in 1 CARTON (51672-1376-3) / 60 g in 1 TUBE 51672-1376-6 1 TUBE in 1 CARTON (51672-1376-6) / 45 g in 1 TUBE

Ingredients (1)

naftifine hydrochloride (20 mg/g)

Linked Drug Pages (1)

Naftifine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4aa35016-7749-87c7-e063-6394a90ac5c6", "openfda": {"unii": ["25UR9N9041"], "rxcui": ["1433734"], "spl_set_id": ["92d3ec30-2176-49cd-8a70-668ef65e7663"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1376-3)  / 60 g in 1 TUBE", "package_ndc": "51672-1376-3", "marketing_start_date": "20230401"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1376-6)  / 45 g in 1 TUBE", "package_ndc": "51672-1376-6", "marketing_start_date": "20230401"}], "brand_name": "Naftifine Hydrochloride", "product_id": "51672-1376_4aa35016-7749-87c7-e063-6394a90ac5c6", "dosage_form": "GEL", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "51672-1376", "generic_name": "Naftifine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naftifine Hydrochloride", "active_ingredients": [{"name": "NAFTIFINE HYDROCHLORIDE", "strength": "20 mg/g"}], "application_number": "ANDA208201", "marketing_category": "ANDA", "marketing_start_date": "20230401", "listing_expiration_date": "20271231"}