NDC 17856-0798

Divalproex Sodium

Divalproex Sodium

Divalproex Sodium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Divalproex Sodium.

Product ID17856-0798_23e87b0e-9ede-4fc8-aeb9-67003a2a42b5
NDC17856-0798
Product TypeHuman Prescription Drug
Proprietary NameDivalproex Sodium
Generic NameDivalproex Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-10-29
Marketing CategoryANDA / ANDA
Application NumberANDA078597
Labeler NameATLANTIC BIOLOGICALS CORP.
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 17856-0798-1

100 POUCH in 1 CASE (17856-0798-1) > 1 TABLET, DELAYED RELEASE in 1 POUCH
Marketing Start Date2018-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0798-1 [17856079801]

Divalproex Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:3c95fce8-42d7-432a-adeb-1e79f9c3d5f3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099870
  • 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.