Terbinafine Hydrochloride
These highlights do not include all the information needed to use TERBINAFINE TABLETS, USP safely and effectively. See full prescribing information for TERBINAFINE TABLETS, USP. TERBINAFINE TABLETS, USP 250 mg For oral use Initial U.S. Approval: 1992
Approved
Approval ID
89220c91-78bc-416f-b40a-af5fadc2ea6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-792
Application NumberANDA077137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (7)
Terbinafine HydrochlorideActive
Quantity: 250 mg in 1 1
Code: 012C11ZU6G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT