NDC 64725-0315

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 Tya Pharmaceuticals. The primary component is Divalproex Sodium.

Product ID64725-0315_af3febff-f6b0-4bb3-9f83-142ef96135e9
NDC64725-0315
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 CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021168
Labeler NameTYA Pharmaceuticals
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-0315-1

15 TABLET, EXTENDED RELEASE in 1 CONTAINER (64725-0315-1)
Marketing Start Date2013-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-0315-1 [64725031501]

Divalproex Sodium Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-12
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:49a585a8-327a-44b2-b45b-7a0959724dc6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099563
  • 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

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