NDC 43063-295

Divalproex Sodium Extended Release

Divalproex Sodium

Divalproex Sodium Extended Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Divalproex Sodium.

Product ID43063-295_737bec9d-081d-27cb-e053-2991aa0a873d
NDC43063-295
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium Extended Release
Generic NameDivalproex Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-08-04
Marketing CategoryANDA / ANDA
Application NumberANDA078445
Labeler NamePD-Rx Pharmaceuticals, 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 43063-295-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-295-30)
Marketing Start Date2009-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-295-30 [43063029530]

Divalproex Sodium Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-31

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:c628d376-4b65-4f05-b6fa-eabb1d96a7df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099569
    • UPC Code
  • 0343063295304

    • 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
    68382-315Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    68382-314Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    70518-1498Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    10370-510Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    10370-511Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    43063-295Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    50090-3913Divalproex Sodium Extended ReleaseDivalproex Sodium Extended Release
    70518-2497Divalproex 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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