NDC 55648-725

DIVALPROEX SODIUM ER

Divalproex Sodium

DIVALPROEX SODIUM ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Divalproex Sodium.

Product ID55648-725_f8aa46d8-270b-48ea-95fc-5febb7b8ddab
NDC55648-725
Product TypeHuman Prescription Drug
Proprietary NameDIVALPROEX SODIUM ER
Generic NameDivalproex Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-08-04
Marketing CategoryANDA / ANDA
Application NumberANDA078705
Labeler NameWOCKHARDT LIMITED
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 Through2018-12-31

Packaging

NDC 55648-725-02

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-725-02)
Marketing Start Date2009-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-725-04 [55648072504]

DIVALPROEX SODIUM ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-04
Inactivation Date2020-01-31

NDC 55648-725-03 [55648072503]

DIVALPROEX SODIUM ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-04
Inactivation Date2020-01-31

NDC 55648-725-01 [55648072501]

DIVALPROEX SODIUM ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-04
Inactivation Date2020-01-31

NDC 55648-725-02 [55648072502]

DIVALPROEX SODIUM ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:da69287c-2f37-4299-b444-914c1ab0054c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099563
  • 1099569
    • UPC Code
  • 0364679725023
  • 0364679724026

    • Pharmacological Class

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

    NDC Crossover Matching brand name "DIVALPROEX SODIUM ER" or generic name "Divalproex Sodium"

    NDCBrand NameGeneric Name
    55648-724DIVALPROEX SODIUM ERDIVALPROEX SODIUM ER
    55648-725DIVALPROEX SODIUM ERDIVALPROEX SODIUM ER
    64679-725Divalproex Sodium ERDivalproex Sodium ER
    64679-724Divalproex Sodium ERDivalproex Sodium ER
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium
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