NDC 70518-1759

Depakote ER

Divalproex Sodium

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

• Product ID: 70518-1759_7e80dcd1-a8ea-d229-e053-2991aa0a5377
• NDC: 70518-1759
• Product Type: Human Prescription Drug
• Proprietary Name: Depakote ER
• Generic Name: Divalproex Sodium
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA021168
• Labeler Name: REMEDYREPACK INC.
• Substance Name: DIVALPROEX SODIUM
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-1759-0

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-1759-0)

• Marketing Start Date: 2019-01-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1759-0 [70518175900]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-02

Drug Details

Active Ingredients

Ingredient	Strength
DIVALPROEX SODIUM	500 mg/1

OpenFDA Data

• SPL SET ID: ea5681e8-bc5a-429d-ba85-b04c527c1cdd
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 644VL95AO6
• RxNorm Concept Unique ID - RxCUI:
  • 1099571
  • 1099569

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
70518-1758	Depakote ER	Depakote ER
70518-1759	Depakote ER	Depakote ER
43353-310	Depakote ER	Depakote ER
63629-3370	Depakote ER	Depakote ER
0074-3826	Depakote	Divalproex Sodium
0074-6114	Depakote	Divalproex Sodium
0074-6212	Depakote	Divalproex Sodium
0074-6214	Depakote	Divalproex Sodium
0074-6215	Depakote	Divalproex Sodium
0074-7126	Depakote	Divalproex Sodium