Valacyclovir (Page 8 of 8)

Label

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Label

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VALACYCLOVIR
valacyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69117-0010
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Y131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69117-0010-1 30 TABLET in 1 BOTTLE None
2 NDC:69117-0010-2 90 TABLET in 1 BOTTLE None
3 NDC:69117-0010-3 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209553 10/01/2018
VALACYCLOVIR
valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69117-0011
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code Y132
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69117-0011-1 30 TABLET in 1 BOTTLE None
2 NDC:69117-0011-2 90 TABLET in 1 BOTTLE None
3 NDC:69117-0011-3 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209553 10/01/2018
Labeler — Yiling Pharmaceutical, Inc. (079417422)
Establishment
Name Address ID/FEI Operations
Yiling Pharmaceutical Ltd 544322244 manufacture (69117-0011), manufacture (69117-0010)

Revised: 07/2020 Yiling Pharmaceutical, Inc.

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