Terbinafine

FDA Drug Profile — Toenail Fungus Treatment, Terbinafine, TERBINAFINE

Terbinafine is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including Toenail Fungus Treatment, Terbinafine, TERBINAFINE. Available dosage forms: liquid, powder, tablet.

Drug Details

Generic Name
Terbinafine
Brand Names
Toenail Fungus Treatment, Terbinafine, TERBINAFINE
Application Number
M005
Sponsor
Shenzhen Wankelai E-commerce Co., Ltd.
NDC Codes
8
Dosage Forms
LIQUID, POWDER, TABLET
Routes
TOPICAL, ORAL
Active Ingredients
TERBINAFINE, TERBINAFINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). (1)