Valproate Sodium
These highlights do not include all the information needed to use VALPROATE SODIUM INJECTION safely and effectively. See full prescribing information for VALPROATE SODIUM INJECTION. VALPROATE SODIUM injection, for intravenous injection onlyInitial U.S. Approval: 1996
Approved
Approval ID
3dfb6da1-f66a-4618-9f74-d2d6c16c0b58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VALPROATE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-494
Application NumberANDA076539
Product Classification
M
Marketing Category
C73584
G
Generic Name
VALPROATE SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.4 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
VALPROATE SODIUMActive
Quantity: 100 mg in 1 mL
Code: 5VOM6GYJ0D
Classification: ACTIM