Lamotrigine
- Product NDC
- 51672-4133
- 11-digit product format
- 516724133
- Labeler code
- 51672
- Product ID
- 51672-4133_44812d3c-0fc0-67dd-e063-6394a90a9d70
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078525
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- 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
- 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 |
|---|
| 51672-4133-0 | 51672413300 | 10 BLISTER PACK in 1 CARTON (51672-4133-0) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2009-01-27 | No | No | Historical |
| 51672-4133-1 | 51672413301 | 100 TABLET in 1 BOTTLE (51672-4133-1) | 100 tablet | 2009-01-27 | No | No | Historical |
| 51672-4133-2 | 51672413302 | 500 TABLET in 1 BOTTLE (51672-4133-2) | 500 tablet | 2022-10-25 | No | No | Historical |
| 51672-4133-3 | 51672413303 | 1000 TABLET in 1 BOTTLE (51672-4133-3) | 1000 tablet | 2009-01-27 | No | No | Historical |
| 51672-4133-4 | 51672413304 | 60 TABLET in 1 BOTTLE (51672-4133-4) | 60 tablet | 2009-01-27 | No | No | Historical |
| 51672-4133-6 | 51672413306 | 30 TABLET in 1 BOTTLE (51672-4133-6) | 30 tablet | 2009-01-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd. | 2025-11-26 | HUMAN PRESCRIPTION DRUG LABEL | 21 |
| Lamotrigine | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd. | 2023-05-09 | HUMAN PRESCRIPTION DRUG LABEL | 15 |
| Lamotrigine | Rebel Distributors Corp | 2010-09-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |