Drugplain

Lamotrigine Extended Release 250 mg/1

lamotrigine extended release · TABLET · Par Health USA, LLC

3 Recalls on RecordCurrently in Shortage
Plain English

Lamotrigine Extended Release is a prescription tablet used to treat seizures in epilepsy and to help prevent mood episodes in bipolar disorder. This medication is an anti-epileptic agent that works by stabilizing electrical activity in the brain.

Key Facts

Brand Name
Lamotrigine Extended Release
Generic Name
lamotrigine extended release
NDC Code (Product)
49884-604
Manufacturer
Par Health USA, LLC
Strength
250 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA201791
Drug Class
Anti-epileptic Agent [EPC]; Mood Stabilizer [EPC]
Marketing Start
01/18/2013

Recall History

3 Recalls on Record
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II09/11/2018

Torrent Pharma Inc.

Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Lamotrigine Extended Release used for?

Lamotrigine Extended Release is a prescription tablet used to treat seizures in epilepsy and to help prevent mood episodes in bipolar disorder. This medication is an anti-epileptic agent that works by stabilizing electrical activity in the brain.

Is Lamotrigine Extended Release a controlled substance?

Lamotrigine Extended Release is not classified as a controlled substance by the DEA.

What is the generic name for Lamotrigine Extended Release?

The generic name for Lamotrigine Extended Release is lamotrigine extended release. There are no other listed brand versions of lamotrigine extended release.

What is the NDC code for Lamotrigine Extended Release 250 mg/1?

The NDC (National Drug Code) for Lamotrigine Extended Release 250 mg/1 is 49884-604, listed by Par Health USA, LLC.

Product NDC

49884-604

Package NDC

49884-604-11

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)