Lamotrigine
- Product NDC
- 50228-321
- 11-digit product format
- 502280321
- Labeler code
- 50228
- Product ID
- 50228-321_ec9440ec-0301-59bb-e053-2a95a90afe94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA206382
- Marketing category
- ANDA
- Marketing start
- 2015-11-30
- Substance
- LAMOTRIGINE
- Active strength
- 100 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U3H27498KS | LAMOTRIGINE | 84057-84-1 | LAMOTRIGINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50228-321-01 | 50228032101 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-321-01) | 2015-11-30 | No | No | Historical |
| 50228-321-30 | 50228032130 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-321-30) | 2015-11-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | ScieGen Pharmaceuticals, Inc. | 2022-11-03 | HUMAN PRESCRIPTION DRUG LABEL | 7 |