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
a9cef1ec-ba52-4849-8889-87898d6f4199
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 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 Code63629-2454
Application NumberANDA073484
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2020
FDA Product Classification
INGREDIENTS (7)
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
VALPROIC ACIDActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB