Lamotrigine ER
- Product NDC
- 72189-560
- 11-digit product format
- 721890560
- Labeler code
- 72189
- Product ID
- 72189-560_1b42a7cf-86d9-e506-e063-6394a90a3c9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine ER
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_rx
- Application
- ANDA213949
- Marketing category
- ANDA
- Marketing start
- 2024-06-19
- 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 |
|---|
| 72189-560-30 | 72189056030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-560-30) | 2024-06-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine ER | Direct_rx | 2024-06-19 | HUMAN PRESCRIPTION DRUG LABEL | 1 |