VALACYCLOVIR - valacyclovir tablet, film coated 
Zydus Lifesciences Limited

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VALACYCLOVIR TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-629-06 in bottle of 30 tablets

Valacyclovir Tablets USP, 500 mg

Rx only

30 tablets

Valacyclovir tablets

NDC 65841-630-06 in bottle of 30 tablets

Valacyclovir Tablets USP, 1 gram

Rx only

30 tablets

Valacyclovir tablets
VALACYCLOVIR 
valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-629
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (CAPSULE) Size 18mm
Flavor Imprint Code 500
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65841-629-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018
2 NDC:65841-629-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018
3 NDC:65841-629-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018
4 NDC:65841-629-77 10 in 1 CARTON 04/05/2018
4 NDC:65841-629-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079137 04/05/2018
VALACYCLOVIR 
valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-630
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR 1000 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape OVAL (CAPSULE) Size 23mm
Flavor Imprint Code 1000
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65841-630-34 21 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018
2 NDC:65841-630-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018
3 NDC:65841-630-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079137 04/05/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 918596198 ANALYSIS(65841-629, 65841-630) , MANUFACTURE(65841-629, 65841-630)

Revised: 11/2022
Document Id: aa80b623-2abf-418e-bded-79666b225353
Set id: 91832fd8-0d76-4408-9d26-9d5f52c47670
Version: 4
Effective Time: 20221105
 
Zydus Lifesciences Limited