Drugplain

Tiagabine Hydrochloride 16 mg/1

Tiagabine Hydrochloride · TABLET, FILM COATED · Teva Pharmaceuticals USA, Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Tiagabine hydrochloride is a prescription medication taken by mouth that is used to help control seizures in people with epilepsy. It works by affecting certain chemicals in the brain that are involved in seizure activity.

Key Facts

Brand Name
Tiagabine Hydrochloride
Generic Name
Tiagabine Hydrochloride
NDC Code (Product)
0093-8076
Manufacturer
Teva Pharmaceuticals USA, Inc.
Strength
16 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA020646
Marketing Start
03/09/2018

Recall History

1 Recall on Record
Class II07/10/2023

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

encephalopathy16 reports
myoclonus14 reports
off label use13 reports
drug ineffective10 reports
dizziness6 reports
feeling abnormal5 reports
seizure5 reports
product use in unapproved indication4 reports
serotonin syndrome4 reports
toxicity to various agents4 reports

Frequently Asked Questions

What is Tiagabine Hydrochloride used for?

Tiagabine hydrochloride is a prescription medication taken by mouth that is used to help control seizures in people with epilepsy. It works by affecting certain chemicals in the brain that are involved in seizure activity.

Is Tiagabine Hydrochloride a controlled substance?

Tiagabine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Tiagabine Hydrochloride?

The generic name for Tiagabine Hydrochloride is Tiagabine Hydrochloride. There are 2 other brand versions of Tiagabine Hydrochloride.

What is the NDC code for Tiagabine Hydrochloride 16 mg/1?

The NDC (National Drug Code) for Tiagabine Hydrochloride 16 mg/1 is 0093-8076, listed by Teva Pharmaceuticals USA, Inc..