VALPROIC ACID
These highlights do not include all the information needed to use valproic acid safely and effectively. See full prescribing information for valproic acid oral solution USP. Valproic acid oral solution, USP Initial U.S. Approval: 1978
Approved
Approval ID
db53c5aa-d7a5-49ba-8227-c2d67ced23e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VALPROIC ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-2250
Application NumberANDA075379
Product Classification
M
Marketing Category
C73584
G
Generic Name
VALPROIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification
INGREDIENTS (9)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
VALPROIC ACIDActive
Quantity: 250 mg in 5 mL
Code: 614OI1Z5WI
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT