valproic acid
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 capsules, for oral use Initial U.S. Approval: 1978
Approved
Approval ID
7d4df6ad-3d53-4664-9200-749487bf3689
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code0832-0310
Application NumberANDA073229
Product Classification
M
Marketing Category
C73584
G
Generic Name
valproic acid
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2020
FDA Product Classification
INGREDIENTS (5)
valproic acidActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
peanut oilInactive
Code: 5TL50QU0W4
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT