NDC 70518-1456

Depakote

Divalproex Sodium

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

Product ID70518-1456_774aba77-e69a-0e0a-e053-2991aa0a8083
NDC70518-1456
Product TypeHuman Prescription Drug
Proprietary NameDepakote
Generic NameDivalproex Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-10-02
Marketing CategoryNDA / NDA
Application NumberNDA018723
Labeler NameREMEDYREPACK 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
Listing Certified Through2019-12-31

Packaging

NDC 70518-1456-0

30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1456-0)
Marketing Start Date2018-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1456-0 [70518145600]

Depakote TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA018723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-02

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:86fd7d4d-20d4-4483-8e45-f2942503f367
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099871
  • 1099870
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium
    70518-1456DepakoteDepakote
    70518-1454DepakoteDepakote
    21695-359DepakoteDepakote
    21695-163DepakoteDepakote

    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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