NDC 53808-1061

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 State Of Florida Doh Central Pharmacy. The primary component is Divalproex Sodium.

Product ID53808-1061_77f11b3f-cb30-432a-aa27-9c9286c91da2
NDC53808-1061
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium Extended-Release
Generic NameDivalproex Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021168
Labeler NameState of Florida DOH Central Pharmacy
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
Listing Certified Through2019-12-31

Packaging

NDC 53808-1061-1

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-1061-1)
Marketing Start Date2014-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-1061-1 [53808106101]

Divalproex Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:01c035ee-6bed-431d-9324-e0e0bc507eae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099569

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    53808-1061Divalproex Sodium Extended-ReleaseDivalproex Sodium Extended-Release
    64725-0314Divalproex Sodium Extended-ReleaseDivalproex Sodium Extended-Release
    64725-0315Divalproex Sodium Extended-ReleaseDivalproex Sodium Extended-Release
    67046-143Divalproex Sodium Extended-ReleaseDivalproex Sodium Extended-Release
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.