Valacyclovir Hydrochloride (Page 8 of 8)

Valacyclovir 1 Gram Caplets

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Valacyclovir 500mg Caplets

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VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-0061(NDC:57237-043)
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:53002-0061-1 2 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:53002-0061-2 4 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:53002-0061-3 10 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:53002-0061-4 14 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:53002-0061-5 20 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:53002-0061-6 21 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:53002-0061-0 30 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 HYDROCHLORIDE valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-7830(NDC:57237-042)
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:53002-7830-6 6 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:53002-7830-1 10 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:53002-7830-2 20 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:53002-7830-3 30 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 — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-7830), RELABEL (53002-0061), REPACK (53002-0061), REPACK (53002-7830)

Revised: 10/2018 RPK Pharmaceuticals, Inc.

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