NDC 0074-3826

Depakote ER

Divalproex Sodium

Depakote ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Divalproex Sodium.

Product ID0074-3826_0ea6f3b9-d1cc-cd2c-c486-f89694498d58
NDC0074-3826
Product TypeHuman Prescription Drug
Proprietary NameDepakote ER
Generic NameDivalproex Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-08-04
Marketing CategoryNDA / NDA
Application NumberNDA021168
Labeler NameAbbVie Inc.
Substance NameDIVALPROEX SODIUM
Active Ingredient Strength250 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0074-3826-13

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3826-13)
Marketing Start Date2000-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0074-3826-72 [00074382672]

Depakote ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-11
Marketing End Date2013-09-16

NDC 0074-3826-11 [00074382611]

Depakote ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-08-04

NDC 0074-3826-60 [00074382660]

Depakote ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-08-04
Marketing End Date2013-09-16

NDC 0074-3826-13 [00074382613]

Depakote ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-08-04

NDC 0074-3826-53 [00074382653]

Depakote ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-08-04
Marketing End Date2013-09-16

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM250 mg/1

OpenFDA Data

SPL SET ID:0dc024ce-efc8-4690-7cb5-639c728fccac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099563
  • 1099571
  • 1099569
  • 1099565
    • UPC Code
  • 0300747126132
  • 0300743826135

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Mood Stabilizer [EPC]

    NDC Crossover Matching brand name "Depakote ER" or generic name "Divalproex Sodium"

    NDCBrand NameGeneric Name
    70518-1758Depakote ERDepakote ER
    70518-1759Depakote ERDepakote ER
    43353-310Depakote ERDepakote ER
    63629-3370Depakote ERDepakote ER
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium

    Trademark Results [Depakote]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DEPAKOTE
    DEPAKOTE
    75295484 2197507 Dead/Cancelled
    SANOFI-AVENTIS
    1997-05-21
    DEPAKOTE
    DEPAKOTE
    73383028 1377834 Live/Registered
    SANOFI
    1982-09-01
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