VALACYCLOVIR- valacyclovir tablet, film coated 
Zydus Lifesciences Limited

----------

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-629
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE) Scoreno score
ShapeOVAL (CAPSULE) Size18mm
FlavorImprint Code 500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-629-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201803/25/2025
2NDC:65841-629-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201803/25/2025
3NDC:65841-629-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201803/25/2025
4NDC:65841-629-7710 in 1 CARTON04/05/201803/25/2025
4NDC:65841-629-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07913704/05/201808/23/2025
VALACYCLOVIR 
valacyclovir tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-630
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR1000 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE) Score2 pieces
ShapeOVAL (CAPSULE) Size23mm
FlavorImprint Code 1000
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-630-3421 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201803/25/2025
2NDC:65841-630-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201803/25/2025
3NDC:65841-630-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/05/201803/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07913704/05/201808/23/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-629, 65841-630) , MANUFACTURE(65841-629, 65841-630)

Revised: 8/2025
Document Id: 1da0d6e5-10cf-4b95-9154-dad6064d12b2
Set id: 91832fd8-0d76-4408-9d26-9d5f52c47670
Version: 5
Effective Time: 20250823
 
Zydus Lifesciences Limited