Lamotrigine
- Product NDC
- 82804-105
- 11-digit product format
- 828040105
- Labeler code
- 82804
- Product ID
- 82804-105_ffa46cb2-16e7-45f3-9940-5cb88d0cda9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203370
- Marketing category
- ANDA
- Marketing start
- 2013-12-23
- 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 |
|---|
| 82804-105-30 | 82804010530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-30) | 2024-05-13 | No | No | Historical |
| 82804-105-60 | 82804010560 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-60) | 2024-05-13 | No | No | Historical |
| 82804-105-90 | 82804010590 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-90) | 2024-05-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Proficient Rx LP | 2024-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |