Lamotrigine
- Product NDC
- 80425-0289
- 11-digit product format
- 804250289
- Labeler code
- 80425
- Product ID
- 80425-0289_2a9b9724-0258-e829-e063-6394a90a1c07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2023-03-24
- Substance
- LAMOTRIGINE
- Active strength
- 25 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 |
|---|
| 80425-0289-1 | 80425028901 | 30 TABLET in 1 BOTTLE (80425-0289-1) | 30 tablet | 2023-03-24 | No | No | Historical |
| 80425-0289-2 | 80425028902 | 60 TABLET in 1 BOTTLE (80425-0289-2) | 60 tablet | 2023-03-24 | No | No | Historical |
| 80425-0289-3 | 80425028903 | 90 TABLET in 1 BOTTLE (80425-0289-3) | 90 tablet | 2023-03-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |