Lamotrigine
- Product NDC
- 68788-7168
- 11-digit product format
- 687887168
- Labeler code
- 68788
- Product ID
- 68788-7168_8ffc814c-d2de-4d4b-8199-657c1c4dc859
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2018-06-11
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 200 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 |
|---|
| 68788-7168 | LAMOTRIGINE TABLET [PREFERRED PHARMACEUTICALS INC.] | 7 | Legacy NDC | 20240607_5385bad8-09f2-41ba-9858-19de9c989647.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7168-3 | 68788716803 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-7168-3) | 30 tablet | 2018-06-11 | 0000-00-00 | No | No | Current |
| 68788-7168-6 | 68788716806 | 60 TABLET in 1 BOTTLE, PLASTIC (68788-7168-6) | 60 tablet | 2018-06-11 | 0000-00-00 | No | No | Current |
| 68788-7168-9 | 68788716809 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-7168-9) | 90 tablet | 2018-06-11 | 0000-00-00 | No | No | Current |