Lamotrigine
- Product NDC
- 51672-4132
- 11-digit product format
- 516724132
- Labeler code
- 51672
- Product ID
- 51672-4132_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
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| LAMOTRIGINE | 150 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 198429, 282401 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-4132-0 | 51672413200 | 10 BLISTER PACK in 1 CARTON (51672-4132-0) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2009-01-27 | 0000-00-00 | No | No | Current |
| 51672-4132-1 | 51672413201 | 100 TABLET in 1 BOTTLE (51672-4132-1) | 100 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 51672-4132-2 | 51672413202 | 500 TABLET in 1 BOTTLE (51672-4132-2) | 500 tablet | 2022-10-25 | 0000-00-00 | No | No | Current |
| 51672-4132-3 | 51672413203 | 1000 TABLET in 1 BOTTLE (51672-4132-3) | 1000 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 51672-4132-4 | 51672413204 | 60 TABLET in 1 BOTTLE (51672-4132-4) | 60 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 51672-4132-6 | 51672413206 | 30 TABLET in 1 BOTTLE (51672-4132-6) | 30 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Bryant Ranch Prepack | 2026-05-28 | HUMAN PRESCRIPTION DRUG LABEL | 103 |
| Lamotrigine | Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd. | 2025-11-26 | HUMAN PRESCRIPTION DRUG LABEL | 21 |
| Lamotrigine | Rebel Distributors Corp | 2010-09-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |