butenafine hydrochloride

Generic: butenafine hydrochloride

Labeler: meijer distribution inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butenafine hydrochloride
Generic Name butenafine hydrochloride
Labeler meijer distribution inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

butenafine hydrochloride 10 mg/g

Manufacturer
MEIJER DISTRIBUTION INC

Identifiers & Regulatory

Product NDC 79481-0086
Product ID 79481-0086_39070e62-eb92-10ca-e063-6394a90a7564
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA205181
Listing Expiration 2026-12-31
Marketing Start 2023-11-30

Pharmacologic Class

Classes
benzylamine antifungal [epc] benzylamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 794810086
Hyphenated Format 79481-0086

Supplemental Identifiers

RxCUI
1298448
UNII
R8XA2029ZI

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 butenafine hydrochloride (source: ndc)
Generic Name butenafine hydrochloride (source: ndc)
Application Number ANDA205181 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (79481-0086-1) / 30 g in 1 TUBE
source: ndc

Packages (1)

79481-0086-1 1 TUBE in 1 CARTON (79481-0086-1) / 30 g in 1 TUBE

Ingredients (1)

butenafine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Butenafine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39070e62-eb92-10ca-e063-6394a90a7564", "openfda": {"unii": ["R8XA2029ZI"], "rxcui": ["1298448"], "spl_set_id": ["4e88068b-1449-43b4-9c7c-4ad8e877459b"], "manufacturer_name": ["MEIJER DISTRIBUTION INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (79481-0086-1)  / 30 g in 1 TUBE", "package_ndc": "79481-0086-1", "marketing_start_date": "20231130"}], "brand_name": "Butenafine Hydrochloride", "product_id": "79481-0086_39070e62-eb92-10ca-e063-6394a90a7564", "dosage_form": "CREAM", "pharm_class": ["Benzylamine Antifungal [EPC]", "Benzylamines [CS]"], "product_ndc": "79481-0086", "generic_name": "Butenafine Hydrochloride", "labeler_name": "MEIJER DISTRIBUTION INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Butenafine Hydrochloride", "active_ingredients": [{"name": "BUTENAFINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "ANDA205181", "marketing_category": "ANDA", "marketing_start_date": "20231130", "listing_expiration_date": "20261231"}