Lamotrigine
- Product NDC
- 46708-276
- 11-digit product format
- 467080276
- Labeler code
- 46708
- Product ID
- 46708-276_1f960fe8-22d3-4836-9d4e-f53d74a6c590
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA090607
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Substance
- LAMOTRIGINE
- Active strength
- 150 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-276-30 | 46708027630 | 30 TABLET in 1 BOTTLE (46708-276-30) | 30 tablet | 2013-01-01 | No | No | Historical |
| 46708-276-31 | 46708027631 | 100 TABLET in 1 BOTTLE (46708-276-31) | 100 tablet | 2013-01-01 | No | No | Historical |
| 46708-276-60 | 46708027660 | 60 TABLET in 1 BOTTLE (46708-276-60) | 60 tablet | 2013-01-01 | No | No | Historical |
| 46708-276-71 | 46708027671 | 500 TABLET in 1 BOTTLE (46708-276-71) | 500 tablet | 2013-01-01 | No | No | Historical |
| 46708-276-91 | 46708027691 | 1000 TABLET in 1 BOTTLE (46708-276-91) | 1000 tablet | 2013-01-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Alembic Pharmaceuticals Limited | 2023-01-27 | Human Prescription Drug Label | 5 |