NDC 63629-3370

Depakote ER

Divalproex Sodium

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

• Product ID: 63629-3370_209f343f-13a2-4cfe-b666-2371d7a3f04e
• NDC: 63629-3370
• 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: 2000-08-04
• Marketing Category: NDA / NDA
• Application Number: NDA021168
• Labeler Name: Bryant Ranch Prepack
• 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: 2021-12-31

Packaging

NDC 63629-3370-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-3370-1)

• Marketing Start Date: 2007-02-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63629-3370-1 [63629337001]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-06-07
• Inactivation Date: 2019-11-27

NDC 63629-3370-2 [63629337002]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-06-07
• Inactivation Date: 2019-11-27

NDC 63629-3370-3 [63629337003]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-06-07
• Inactivation Date: 2019-11-27

NDC 63629-3370-4 [63629337004]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-06-07
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
DIVALPROEX SODIUM	500 mg/1

OpenFDA Data

• SPL SET ID: 942c853a-9eb9-4454-b686-b45d8df8db39
• Manufacturer:
  • Bryant Ranch Prepack
• 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