NDC 43353-310

Depakote ER

Divalproex Sodium

Depakote ER is a Oral Tablet, 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 ID: 43353-310_ca87b71c-a13f-4675-b686-e8af41f108b4
• NDC: 43353-310
• 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: Aphena Pharma Solutions - Tennessee, LLC
• 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: 2019-12-31

Packaging

NDC 43353-310-60

90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-310-60)

• Marketing Start Date: 2000-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-310-60 [43353031060]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-08-04
• Inactivation Date: 2020-01-31

NDC 43353-310-53 [43353031053]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-08-04
• Inactivation Date: 2020-01-31

NDC 43353-310-80 [43353031080]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-08-04
• Inactivation Date: 2020-01-31

NDC 43353-310-70 [43353031070]

Depakote ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-08-04
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DIVALPROEX SODIUM	500 mg/1

OpenFDA Data

• SPL SET ID: 7bc942e3-b976-4b5c-8874-2a1c7dd3d2f1
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• 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