NDC Code(s) : 0054-0198-13, 0054-0197-13, 0054-0196-13
Packager : West-Ward Pharmaceuticals Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FamciclovirFamciclovir TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0198
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR(UNII: QIC03ANI02)
(PENCICLOVIR - UNII:359HUE8FJC) 		FAMCICLOVIR500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 54;225
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0054-0198-1330 in 1 BOTTLE Type 0: Not a Combination Product01/03/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090128 01/03/2011 02/09/2019
FamciclovirFamciclovir TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0197
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR(UNII: QIC03ANI02)
(PENCICLOVIR - UNII:359HUE8FJC) 		FAMCICLOVIR250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code 54;315
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0054-0197-1330 in 1 BOTTLE Type 0: Not a Combination Product01/03/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090128 01/03/2011 02/09/2019
FamciclovirFamciclovir TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0196
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR(UNII: QIC03ANI02)
(PENCICLOVIR - UNII:359HUE8FJC) 		FAMCICLOVIR125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM(UNII: D1JT611TNE)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 54;127
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0054-0196-1330 in 1 BOTTLE Type 0: Not a Combination Product01/03/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090128 01/03/2011 02/09/2019

PRINCIPAL DISPLAY PANEL

fpl-bl-125mg-30tab-05.jpg

PRINCIPAL DISPLAY PANEL

fpl-bl-250mg-30tab-05.jpg

PRINCIPAL DISPLAY PANEL

fpl-bl-500mg-30tab-05.jpg