DIVALPROEX SODIUM- divalproex sodium capsule, coated pellets 
Zydus Lifesciences Limited

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DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-639-01 in bottle of 100 Capsules

Divalproex sodium delayed-release capsules, USP (sprinkle)

Rx only

100 capsules

Divalproex Sodium Capsules Sprinkle, 125 mg
DIVALPROEX SODIUM 
divalproex sodium capsule, coated pellets
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-639
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID125 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size22mm
FlavorImprint Code ZA66;125mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-639-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
2NDC:65841-639-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
3NDC:65841-639-3010 in 1 CARTON01/27/2009
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891901/27/2009
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-639) , MANUFACTURE(65841-639)

Revised: 11/2024
Document Id: 9b43fd1a-165d-420e-ba4f-f7bfaea4c283
Set id: b0f33792-dd96-40cc-a28e-acdcdca2f4b8
Version: 9
Effective Time: 20241128
 
Zydus Lifesciences Limited