Lamotrigine
- Product NDC
- 68788-6868
- 11-digit product format
- 687886868
- Labeler code
- 68788
- Product ID
- 68788-6868_bde8497d-bb56-45af-b109-790bba94e2ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202383
- Marketing category
- ANDA
- Marketing start
- 2017-01-11
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-6868 | LAMOTRIGINE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 9 | Legacy NDC | 20240607_b7fd8b02-5699-48ae-a044-157894438cf0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-6868-1 | 68788686801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-1) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6868-2 | 68788686802 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-2) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6868-3 | 68788686803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-3) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6868-6 | 68788686806 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-6) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6868-8 | 68788686808 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-8) | 2017-01-11 | 0000-00-00 | No | No | Current |
| 68788-6868-9 | 68788686809 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-6868-9) | 2017-01-11 | 0000-00-00 | No | No | Current |