Lamotrigine
- Product NDC
- 46708-417
- 11-digit product format
- 467080417
- Labeler code
- 46708
- Product ID
- 46708-417_faee013c-cad2-4abb-904c-e6ff79ba778c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA211821
- Marketing category
- ANDA
- Marketing start
- 2024-10-07
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-417-30 | 46708041730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-30) | 2024-10-07 | No | No | Historical |
| 46708-417-91 | 46708041791 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-91) | 2024-10-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Alembic Pharmaceuticals Limited | 2024-10-11 | Human Prescription Drug Label | 1 |