MedPath

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, USP for oral useUSP Initial U.S. Approval: 1978

Approved
Approval ID

c628829c-74de-485a-b6cb-42e1da894376

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2015

Manufacturers
FDA

Banner Life Sciences LLC.

DUNS: 079579273

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 Code69387-107
Application NumberANDA073484
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 8, 2015
Generic NameValproic Acid

INGREDIENTS (7)

Corn oilInactive
Code: 8470G57WFM
Classification: IACT
Valproic AcidActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB
GelatinInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
© Copyright 2025. All Rights Reserved by MedPath
Valproic Acid - FDA Approval | MedPath