Valproate Sodium
These highlights do not include all the information needed to use VALPROATE SODIUM INJECTION, USP safely and effectively. See full prescribing information for . for intravenous injection Initial U.S. Approval: 1996
Approved
Approval ID
7a687b2f-246d-4736-a20c-92421c263268
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-9637
Application NumberANDA078523
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valproate Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (5)
VALPROATE SODIUMActive
Quantity: 100 mg in 1 mL
Code: 5VOM6GYJ0D
Classification: ACTIM
EDETATE DISODIUMInactive
Quantity: 0.40 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT