Valacyclovir (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (90 Tablet Bottle)

NDC 52343-051-90
Valacyclovir Tablets, USP
500 mg
PHARMACIST: Dispense the patient
information leaflet with the drug product.
Rx only 90 Tablets GEN-SOURCE RX

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (90 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 gram (90 Tablet Bottle)

NDC 52343-052-90
Valacyclovir Tablets, USP
1 gram
PHARMACIST: Dispense the patient
informaiton leaflet with the drug product.
Rx only 90 Tablets GEN-SOURCE RX

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 1 gram (100 Tablet Bottle)
(click image for full-size original)
VALACYCLOVIR valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-051
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
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code F;82
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52343-051-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52343-051-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 05/24/2010
VALACYCLOVIR valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-052
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code F;8;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52343-052-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52343-052-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 05/24/2010
Labeler — Gen-Source Rx (011951266)

Revised: 10/2013 Gen-Source Rx

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