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
453444b6-1f50-49de-ab3c-1e429c83bffa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2021
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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
NDC Product Code17856-0152
Application NumberANDA073484
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 10, 2021
Generic NameValproic Acid
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VALPROIC ACIDActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB