NDC 53808-0681

Divalproex Sodium Delayed-Release

Divalproex Sodium

Divalproex Sodium Delayed-Release is a Oral Tablet, Film Coated 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 ID53808-0681_dd72b287-cb96-414f-9e0d-a9313d1cbf73
NDC53808-0681
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium Delayed-Release
Generic NameDivalproex Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA090210
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 53808-0681-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0681-1)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0681-1 [53808068101]

Divalproex Sodium Delayed-Release TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090210
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:69f1579d-bf21-468f-8379-531762357f60
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099870

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    53808-0681Divalproex Sodium Delayed-ReleaseDivalproex Sodium Delayed-Release
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium
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