NDC 13668-340 – Lamotrigine
Lamotrigine 50 mg/1 · Tablet, Extended Release · Oral
Product NDC13668-340
Product details
- Brand name
- Lamotrigine
- Generic name
- Lamotrigine
- Labeler
- Torrent Pharmaceuticals Limited
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA203370
- Marketed since
- December 23, 2013
- Listing expires
- December 31, 2027
- Pharmacologic class
- Anti-epileptic Agent; Mood Stabilizer
Active ingredients
- Lamotrigine 50 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 13668-340-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-340-01) | Dec 23, 2013 |
| 13668-340-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-340-05) | Dec 23, 2013 |
| 13668-340-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-340-30) | Dec 23, 2013 |
Recalls mentioning this NDC
- D-1204-2018 Sep 26, 2018 · Class II
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
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