Famciclovir
These highlights do not include all the information needed to use famciclovir tablets safely and effectively. See full prescribing information for famciclovir tablets.FAMCICLOVIR tablets for oral use Initial U.S. Approval: 1994
Approved
Approval ID
405372a1-83bc-4843-b1b2-bd8ff2f83f87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Famciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5905
Application NumberANDA077487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FAMCICLOVIRActive
Quantity: 500 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT