Valacyclovir Hydrochloride (Page 8 of 8)

Valacyclovir Hydrochloride

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Valacyclovir Hydrochloride

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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 (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
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 (ACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
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 05/24/2010
Labeler — McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Corporation 140529962 REPACK (63739-525), REPACK (63739-552)

Revised: 03/2018 McKesson Corporation

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