lamotrigine
- Product NDC
- 70518-4442
- 11-digit product format
- 705184442
- Labeler code
- 70518
- Product ID
- 70518-4442_3c557b30-0f12-70f0-e063-6394a90a1849
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended-release
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213949
- Marketing category
- ANDA
- Marketing start
- 2025-08-14
- Substance
- LAMOTRIGINE
- Active strength
- 50 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 |
|---|
| 70518-4442-0 | 70518444200 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4442-0) | 2025-08-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| lamotrigine | REMEDYREPACK INC. | 2025-08-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |