NDC 0781-2243

Divalproex Sodium Delayed Release (Sprinkle)

Divalproex Sodium

Divalproex Sodium Delayed Release (Sprinkle) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Divalproex Sodium.

Product ID0781-2243_240e4f6f-a947-a5e6-1267-8627cb8ae755
NDC0781-2243
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium Delayed Release (Sprinkle)
Generic NameDivalproex Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-08-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA019680
Labeler NameSandoz Inc.
Substance NameDIVALPROEX SODIUM
Active Ingredient Strength125 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-2243-01

100 CAPSULE in 1 BOTTLE (0781-2243-01)
Marketing Start Date2015-08-31
Marketing End Date2021-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-2243-01 [00781224301]

Divalproex Sodium Delayed Release (Sprinkle) CAPSULE
Marketing CategoryNDA authorized generic
Application NumberNDA019680
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-31

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM125 mg/1

OpenFDA Data

SPL SET ID:e292786a-29f5-a77b-fbef-ef0a6f23ae71
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099596
    • UPC Code
  • 0307812243015

    • 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 (Sprinkle)" or generic name "Divalproex Sodium"

    NDCBrand NameGeneric Name
    0781-2243Divalproex Sodium Delayed Release (Sprinkle)Divalproex Sodium Delayed Release (Sprinkle)
    0074-3826DepakoteDivalproex Sodium
    0074-6114DepakoteDivalproex Sodium
    0074-6212DepakoteDivalproex Sodium
    0074-6214DepakoteDivalproex Sodium
    0074-6215DepakoteDivalproex Sodium
    0074-7126DepakoteDivalproex Sodium
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