Terbinafine Tablets 250 mg

FDA Drug Profile — TERBINAFINE HYDROCHLORIDE

Terbinafine Tablets 250 mg is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including TERBINAFINE HYDROCHLORIDE. Available dosage form: tablet.

Drug Details

Generic Name
Terbinafine Tablets 250 mg
Brand Names
TERBINAFINE HYDROCHLORIDE
Application Number
ANDA077137
Sponsor
NuCare Pharmaceuticals,Inc.
NDC Codes
4
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
TERBINAFINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (1) 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.