DIVALPROEX SODIUM- divalproex sodium tablet, film coated, extended release 
Zydus Lifesciences Limited

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DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS

SPL MEDGUIDE

Manufactured by:

Cadila Healthcare Ltd.

India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-637-01 in bottle of 100 tablets

Divalproex Sodium ER Tablets, 250 mg

Rx only

100 tablets

Structured product formula for Divalproex

NDC 65841-638-01 in bottle of 100 tablets

Divalproex Sodium ER Tablets, 500 mg

Rx only

100 tablets

Structured product formula for Divalproex
DIVALPROEX SODIUM 
divalproex sodium tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-637
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID250 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA47
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-637-1460 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
2NDC:65841-637-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
3NDC:65841-637-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
4NDC:65841-637-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07823901/07/201304/02/2025
DIVALPROEX SODIUM 
divalproex sodium tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-638
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID500 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size23mm
FlavorImprint Code ZA48
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-638-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
2NDC:65841-638-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
3NDC:65841-638-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/07/201303/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07823901/07/201309/19/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-637, 65841-638) , MANUFACTURE(65841-637, 65841-638)

Revised: 9/2025
Document Id: 26712420-739a-4027-8db7-f73d832efbeb
Set id: 4f40e035-fdad-42c9-bd31-c1582215f83e
Version: 9
Effective Time: 20250919
 
Zydus Lifesciences Limited