NDC 71610-205

Divalproex sodium

Divalproex Sodium

Divalproex sodium is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Divalproex Sodium.

Product ID71610-205_4a86282f-831d-4cfe-a814-19a3f544fa85
NDC71610-205
Product TypeHuman Prescription Drug
Proprietary NameDivalproex sodium
Generic NameDivalproex Sodium
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-06-02
Marketing CategoryANDA / ANDA
Application NumberANDA202419
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 Through2020-12-31

Packaging

NDC 71610-205-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-205-30)
Marketing Start Date2018-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-205-60 [71610020560]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 71610-205-53 [71610020553]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 71610-205-30 [71610020530]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 71610-205-70 [71610020570]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 71610-205-80 [71610020580]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM500 mg/1

OpenFDA Data

SPL SET ID:177e34e9-f74d-42aa-8e3c-5fb4f41c2322
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099569

    • Pharmacological Class

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