Lamotrigine
- Product NDC
- 82804-068
- 11-digit product format
- 828040068
- Labeler code
- 82804
- Product ID
- 82804-068_6f7e59d2-4311-42a0-93a0-b29b0417d96f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-068-30 | 82804006830 | 30 TABLET in 1 BOTTLE, PLASTIC (82804-068-30) | 30 tablet | 2024-01-31 | No | No | Historical |
| 82804-068-60 | 82804006860 | 60 TABLET in 1 BOTTLE, PLASTIC (82804-068-60) | 60 tablet | 2024-01-31 | No | No | Historical |
| 82804-068-90 | 82804006890 | 90 TABLET in 1 BOTTLE, PLASTIC (82804-068-90) | 90 tablet | 2024-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Proficient Rx LP | 2024-02-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |