Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL

Label Image for 53808-0635 500mg

Label Image for 500mgLabel Image for 500mg
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0635(NDC:0093-7258)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
POWDERED CELLULOSE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
ALUMINUM OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape OVAL (capsule-shaped) Size 18mm
Flavor Imprint Code 93;7258
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0635-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077655 01/01/2013
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-0635)

Revised: 10/2013 State of Florida DOH Central Pharmacy

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