NDC 82804-105
Lamotrigine 50 mg tablet, extended release
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Torrent Pharma, Inc.'s NDC 13668-340.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- Sep 11, 2018 · Class II · Torrent Pharma Inc.
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Lots: Lot: BFR5D002 EXP 11-2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lamotrigine: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA203370
- On the market since
- Dec 23, 2013
- Package NDCs
82804-105-3082804-105-6082804-105-90- Official label
- DailyMed (National Library of Medicine), updated May 1, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?