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
808dab18-43f1-4895-a023-edbde722863e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-893
Application NumberANDA077714
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2017
FDA Product Classification
INGREDIENTS (6)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Terbinafine HydrochlorideActive
Quantity: 250 mg in 1 1
Code: 012C11ZU6G
Classification: ACTIM
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT