NDC 0904-6363

Divalproex Sodium

Divalproex Sodium

Divalproex Sodium is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Divalproex Sodium.

Product ID0904-6363_09cfd713-6a9e-4e11-a0cf-86e066822920
NDC0904-6363
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium
Generic NameDivalproex Sodium
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-08-11
Marketing CategoryANDA / ANDA
Application NumberANDA090161
Labeler NameMajor Pharmaceuticals
Substance NameDIVALPROEX SODIUM
Active Ingredient Strength250 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 0904-6363-45

80 BLISTER PACK in 1 CARTON (0904-6363-45) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2013-08-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6363-61 [00904636361]

Divalproex Sodium TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090161
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-11

NDC 0904-6363-45 [00904636345]

Divalproex Sodium TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090161
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-11

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM250 mg/1

OpenFDA Data

SPL SET ID:4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099563
  • UPC Code
  • 0309046363453
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68001-105Divalproex SodiumDivalproex Sodium
    68001-106Divalproex SodiumDivalproex Sodium
    68071-4102Divalproex SodiumDivalproex Sodium
    68084-313divalproex sodiumdivalproex sodium
    68084-310Divalproex SodiumDivalproex Sodium
    68084-415Divalproex SodiumDivalproex Sodium
    68084-782Divalproex SodiumDivalproex Sodium
    68084-776Divalproex SodiumDivalproex Sodium
    68151-1164Divalproex SodiumDivalproex Sodium
    68151-4162Divalproex SodiumDivalproex Sodium
    68180-266Divalproex SodiumDivalproex Sodium
    68180-267Divalproex SodiumDivalproex Sodium
    68180-265Divalproex SodiumDivalproex Sodium
    68382-032Divalproex SodiumDivalproex Sodium
    68382-033Divalproex SodiumDivalproex Sodium
    68382-031Divalproex SodiumDivalproex Sodium
    68382-133Divalproex SodiumDivalproex Sodium
    68382-134Divalproex SodiumDivalproex Sodium
    68382-106divalproex sodiumdivalproex sodium
    68788-7183Divalproex SodiumDivalproex Sodium
    68788-7295Divalproex SodiumDivalproex Sodium
    68788-7177Divalproex sodiumDivalproex sodium
    69189-0046Divalproex SodiumDivalproex Sodium
    70518-0282Divalproex SodiumDivalproex Sodium
    70518-0312Divalproex SodiumDivalproex Sodium
    70518-0463Divalproex SodiumDivalproex Sodium
    70518-0613Divalproex SodiumDivalproex Sodium
    70518-0374Divalproex SodiumDivalproex Sodium
    70518-1556Divalproex SodiumDivalproex Sodium
    70518-1661Divalproex SodiumDivalproex Sodium
    70518-1138Divalproex SodiumDivalproex Sodium
    70518-1781Divalproex sodiumDivalproex sodium
    70518-1749divalproex sodiumdivalproex sodium
    70518-1558Divalproex SodiumDivalproex Sodium
    70518-1897Divalproex sodiumDivalproex sodium
    0615-1393Divalproex sodiumDivalproex sodium
    71335-0008Divalproex SodiumDivalproex Sodium
    71610-205Divalproex sodiumDivalproex sodium
    71610-032Divalproex SodiumDivalproex Sodium
    71610-157Divalproex sodiumDivalproex sodium
    71610-201Divalproex SodiumDivalproex Sodium
    71610-030Divalproex SodiumDivalproex Sodium
    0615-7532Divalproex SodiumDivalproex Sodium
    0615-7531Divalproex SodiumDivalproex Sodium
    0615-7533Divalproex SodiumDivalproex Sodium
    0615-7554Divalproex SodiumDivalproex Sodium
    71610-031Divalproex SodiumDivalproex Sodium
    0615-7555Divalproex SodiumDivalproex Sodium
    0615-7848Divalproex SodiumDivalproex Sodium
    0615-7950Divalproex SodiumDivalproex Sodium

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.