Valacyclovir (Page 9 of 9)

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC 51407-107-30

Valacyclovir Tablets, USP

500 mg

Rx only

  1. 30 Tablets
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NDC 51407-108-30

Valacyclovir Tablets, USP

1 gram

Rx only

  1. 30 Tablets
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VALACYCLOVIR
valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-107(NDC:63304-904)
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, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code RX904
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-107-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:51407-107-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076588 01/31/2007
VALACYCLOVIR
valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-108(NDC:63304-905)
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
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 21mm
Flavor Imprint Code RX905
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-108-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:51407-108-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076588 01/31/2007
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-107), repack (51407-107), relabel (51407-108), repack (51407-108)

Revised: 07/2022 Golden State Medical Supply, Inc.

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