TERBINAFINE
TERBINAFINE TABLETS 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
8ea693ec-e2f2-4661-b144-17651018e9fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-572
Application NumberANDA078199
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE, UNSPECIFIEDInactive
Code: Z944H5SN0H
Classification: IACT
TERBINAFINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 012C11ZU6G
Classification: ACTIM