Valproic Acid
These highlights do not include all the information needed to use Valproic Acid Oral Solution safely and effectively. See full prescribing information for Valproic Acid Oral Solution. Valproic Acid Oral Solution, USPInitial U.S. Approval: 1978
Approved
Approval ID
7af84664-7e3b-43f3-a43e-beba36ffb739
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2021
Manufacturers
FDA
Morton Grove Pharmaceuticals, Inc.
DUNS: 801897505
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 Code60432-621
Application NumberANDA070868
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2021
FDA Product Classification
INGREDIENTS (12)
VALPROIC ACIDActive
Quantity: 250 mg in 5 mL
Code: 614OI1Z5WI
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
POTASSIUM PHOSPHATE, DIBASICInactive
Code: CI71S98N1Z
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT