Drugplain

Valproic Acid 250 mg/5mL

Valproic Acid · SOLUTION · Xttrium Laboratories Inc.

5 Recalls on Record
Plain English

Valproic Acid is a solution containing valproic acid at 250 mg/5mL, taken oral. Manufactured by Xttrium Laboratories Inc..

Key Facts

Brand Name
Valproic Acid
Generic Name
Valproic Acid
NDC Code (Product)
0116-4021
Manufacturer
Xttrium Laboratories Inc.
Strength
250 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA070868
Drug Class
Anti-epileptic Agent [EPC]; Mood Stabilizer [EPC]
Marketing Start
07/01/1986

Recall History

5 Recalls on Record
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II09/03/2021

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

CompletedVoluntary: Firm initiated
Class II09/15/2021

American Health Packaging

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

TerminatedVoluntary: Firm initiated
Class II05/22/2015

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

TerminatedVoluntary: Firm initiated
Class III12/10/2012

Upsher Smith Laboratories, Inc.

Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,698 reports
drug interaction3,490 reports
off label use2,101 reports
toxicity to various agents1,966 reports
seizure1,887 reports
completed suicide1,295 reports
somnolence1,263 reports
depression1,220 reports
condition aggravated1,033 reports
overdose944 reports

Frequently Asked Questions

What is Valproic Acid used for?

Valproic Acid contains Valproic Acid. It is a solution taken oral. Consult your doctor for specific uses.

Is Valproic Acid a controlled substance?

Valproic Acid is not classified as a controlled substance by the DEA.

What is the generic name for Valproic Acid?

The generic name for Valproic Acid is Valproic Acid. There are 7 other brand versions of Valproic Acid.

What is the NDC code for Valproic Acid 250 mg/5mL?

The NDC (National Drug Code) for Valproic Acid 250 mg/5mL is 0116-4021, listed by Xttrium Laboratories Inc..