TERBINAFINE HYDROCHLORIDE
These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS.TERBINAFINE tablets,for oral useInitial U.S. Approval: 1992
Approved
Approval ID
daf41866-6f2b-4483-b575-456becd6e85f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2021
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine Tablets 250 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-731
Application NumberANDA077137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine Tablets 250 mg
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2021
FDA Product Classification
INGREDIENTS (3)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TERBINAFINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 012C11ZU6G
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT