NDC 63323-494

Valproate Sodium

Valproate Sodium

Valproate Sodium is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Valproate Sodium.

• Product ID: 63323-494_379dfe33-4ad2-4a1f-9c77-9ded195c87d4
• NDC: 63323-494
• Product Type: Human Prescription Drug
• Proprietary Name: Valproate Sodium
• Generic Name: Valproate Sodium
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2003-08-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076539
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: VALPROATE SODIUM
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 63323-494-16

10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41)

• Marketing Start Date: 2003-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-494-05 [63323049405]

Valproate Sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076539
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-08-18

NDC 63323-494-41 [63323049441]

Valproate Sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076539
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-03

NDC 63323-494-16 [63323049416]

Valproate Sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076539
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-08-18

NDC 63323-494-01 [63323049401]

Valproate Sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076539
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-11

Drug Details

Active Ingredients

Ingredient	Strength
VALPROATE SODIUM	100 mg/mL

OpenFDA Data

• SPL SET ID: c572ece7-03d3-4c2a-aeb5-61f2023b28ea
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 5VOM6GYJ0D
• RxNorm Concept Unique ID - RxCUI:
  • 1099648

Pharmacological Class

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

NDC Crossover Matching brand name "Valproate Sodium" or generic name "Valproate Sodium"

NDC	Brand Name	Generic Name
0143-9637	Valproate Sodium	Valproate Sodium
0143-9785	Valproate Sodium	Valproate Sodium
63323-494	Valproate Sodium	VALPROATE SODIUM
70860-784	Valproate Sodium	valproate sodium
0074-1564	Depacon	Valproate Sodium