Famciclovir (Page 9 of 9)

Package/Label Display Panel

NDC 0093-8117-56

Famciclovir
Tablets125 mg

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION LEAFLET

Rx only

30 TABLETS

Package/Label Display Panel

NDC 0093-8118-56

Famciclovir
Tablets250 mg

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION LEAFLET

Rx only

30 TABLETS

Package/Label Display Panel

NDC 0093-8119-56

Famciclovir
Tablets500 mg

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION LEAFLET

Rx only

30 TABLETS

FAMCICLOVIR famciclovir tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8117 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMCICLOVIR (PENCICLOVIR) FAMCICLOVIR 125 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (50 MPA.S) POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARYL FUMARATE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code 8117;93 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-8117-56 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077487 09/05/2007

FAMCICLOVIR famciclovir tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8118 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMCICLOVIR (PENCICLOVIR) FAMCICLOVIR 250 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (50 MPA.S) POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARYL FUMARATE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 8118;93 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-8118-56 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077487 09/05/2007

FAMCICLOVIR famciclovir tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-8119 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMCICLOVIR (PENCICLOVIR) FAMCICLOVIR 500 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (50 MPA.S) POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARYL FUMARATE TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white Score no score Shape OVAL (capsule-shaped) Size 18mm Flavor Imprint Code 8119;93 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-8119-56 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077487 09/05/2007

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2018 Teva Pharmaceuticals USA, Inc.