Lamotrigine
- Product NDC
- 68071-3514
- 11-digit product format
- 680713514
- Labeler code
- 68071
- Product ID
- 68071-3514_2d04df29-9c20-be48-e063-6294a90a16d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2021-11-17
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3514-6 | 68071351406 | 60 TABLET in 1 BOTTLE (68071-3514-6) | 60 tablet | 2023-09-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | NuCare Pharmaceuticals,Inc. | 2025-01-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |