NDC 0832-7123

Divalproex Sodium

Divalproex Sodium

Divalproex Sodium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Divalproex Sodium.

Product ID0832-7123_0103f7eb-58cb-45e9-bf7b-14e76fb86215
NDC0832-7123
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium
Generic NameDivalproex Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-03-21
Marketing CategoryANDA / ANDA
Application NumberANDA078182
Labeler NameUpsher-Smith Laboratories, LLC
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 Through2023-12-31

Packaging

NDC 0832-7123-01

100 BLISTER PACK in 1 CARTON (0832-7123-01) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0832-7123-89)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0832-7123-11 [00832712311]

Divalproex Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078182
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-21

NDC 0832-7123-01 [00832712301]

Divalproex Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078182
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-01

NDC 0832-7123-89 [00832712389]

Divalproex Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078182
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-26

NDC 0832-7123-15 [00832712315]

Divalproex Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078182
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-21

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM250 mg/1

OpenFDA Data

SPL SET ID:02304a23-4a5f-47bc-9687-4044b43f7a20
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099870
  • 1099625
  • 1099678
  • UPC Code
  • 0308327124110
  • 0308327122116
  • 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.