Label: DIVALPROEX SODIUM capsule, coated pellets

  • NDC Code(s): 65841-639-01, 65841-639-10, 65841-639-30
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 21, 2020

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  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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 - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-639) , MANUFACTURE(65841-639)