Terbinafine Hydrochloride
Terbinafine Hydrochloride Tablets
Approved
Approval ID
dfb8fc2d-4899-4891-a985-755fbdf1d525
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-630
Application NumberANDA077533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbinafine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2010
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TERBINAFINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 012C11ZU6G
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT