Terbinafine
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 use Initial U.S. Approval: 1992
Approved
Approval ID
80aab848-8739-4259-a092-ed99d0f6a56d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2022
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70518-1191
Application NumberANDA077533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2022
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TERBINAFINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 012C11ZU6G
Classification: ACTIM