Lamotrigine
- Product NDC
- 71335-1469
- 11-digit product format
- 713351469
- Labeler code
- 71335
- Product ID
- 71335-1469_917573a6-61bf-4b9c-8eba-cc4c79935072
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA200672
- Marketing category
- ANDA
- Marketing start
- 2016-04-01
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1469-1 | 71335146901 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1469-1) | 2020-01-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Bryant Ranch Prepack | 2024-05-21 | HUMAN PRESCRIPTION DRUG LABEL | 3 |