Famciclovir (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

Famciclovir Tablets 500 mg label
(click image for full-size original)

Famciclovir Tablets 500 mg Label Text

FAMCICLOVIR

Tablets

500 mg

PHARMACIST: PLEASE DISPENSE

WITH ATTACHED PATIENT

INFORMATION LEAFLET

Rx only

FAMCICLOVIR famciclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5905(NDC:0093-8119)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR (FAMCICLOVIR) FAMCICLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOL
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:54868-5905-0 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5905-1 21 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5905-2 03 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:54868-5905-3 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:54868-5905-4 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077487 06/16/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 12/2011 Physicians Total Care, Inc.

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