TERBINAFINE HYDROCHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 078719707

Effective Date

January 5, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Terbinafine(250 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

69097-731

Application Number

ANDA077137

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 5, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: 012C11ZU6GClass: ACTIBQuantity: 250 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT