NDC 71610-289

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 ID71610-289_e84f35bd-ac2b-4066-a275-57b1b07aee58
NDC71610-289
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 Strength250 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 71610-289-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-30)
Marketing Start Date2019-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-289-75 [71610028975]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-05

NDC 71610-289-30 [71610028930]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-05

NDC 71610-289-60 [71610028960]

Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-05

Drug Details

Active Ingredients

IngredientStrength
DIVALPROEX SODIUM250 mg/1

OpenFDA Data

SPL SET ID:9a9f5f24-e421-406f-ac91-d1f964245f54
Manufacturer
UNII

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

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