Valacyclovir Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 500 mg

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

NDC 63739-525-10

Valacyclovir Hydrochloride Tablets 500 mg*

Rx Only

PHARMACIST: Dispense the patient information leaflet with the drug product.

*Each film-coated tablet contains: Valacyclovir hydrochloride equivalent to valacyclovir 500 mg.

Usual Dosage: See prescribing information for Dosage and Administration.

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature].

Keep this and all medication out of the reach of children.

Principal Display Panel — 1 gram

Valacyclovir 1 gram label
(click image for full-size original)

NDC 63739-552-10

Valacyclovir Hydrochloride
Tablets 1 mg*

Rx Only

PHARMACIST: Dispense the patient information leaflet with the drug product.

*Each film-coated tablet contains: Valacyclovir hydrochloride equivalent to valacyclovir 1 mg.

Usual Dosage: See prescribing information for Dosage and Administration.

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature].

Keep this and all medication out of the reach of children.

VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-525(NDC:16714-698)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) 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:63739-525-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-525-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 05/23/2011
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-552(NDC:16714-697)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) 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:63739-552-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-552-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090682 02/24/2012
Labeler — McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Packaging Services a business unit of McKesson Corporation 140529962 REPACK (63739-525), REPACK (63739-552)

Revised: 02/2012 McKesson Packaging Services a business unit of McKesson Corporation

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