Valproic
These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES . VALPROIC ACID Capsule s , for oral use. Initial U.S. Approval: 1978
Approved
Approval ID
cef3e335-5891-412f-89c4-79fcd2f145b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2021
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-4012
Application NumberANDA073229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2021
FDA Product Classification
INGREDIENTS (5)
VALPROIC ACIDActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT