NDC 68382-315

Divalproex Sodium Extended Release

Divalproex Sodium

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

Product ID68382-315_1fa7b430-d238-3949-65dd-8fa90a238148
NDC68382-315
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium Extended Release
Generic NameDivalproex Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-08-12
Marketing End Date2020-01-30
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021168
Labeler NameZydus Pharmaceuticals USA Inc
Substance NameDIVALPROEX SODIUM
Active Ingredient Strength500 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC Exclude FlagN

Packaging

NDC 68382-315-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-315-01)
Marketing Start Date2013-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-315-05 [68382031505]

Divalproex Sodium Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-12
Marketing End Date2019-08-29

NDC 68382-315-01 [68382031501]

Divalproex Sodium Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-12
Marketing End Date2020-01-30

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:44941df2-1f25-706c-6544-b146d109634b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099563
  • 1099569
    • UPC Code
  • 0368382314017
  • 0368382315014

    • Pharmacological Class

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

    Medicade Reported Pricing

    68382031505 DIVALPROEX SOD ER 500 MG TAB

    Pricing Unit: EA | Drug Type:

    68382031501 DIVALPROEX SOD ER 500 MG TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Divalproex Sodium Extended Release" or generic name "Divalproex Sodium"

    NDCBrand NameGeneric Name
    68382-315Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    68382-314Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    70518-1498Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    10370-510Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    10370-511Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    43063-295Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    50090-3913Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    70518-2497Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.