Lamotrigine
- Product NDC
- 71335-0830
- 11-digit product format
- 713350830
- Labeler code
- 71335
- Product ID
- 71335-0830_8bfcaf0d-599d-40e3-b4d9-2897a0e026a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-0830-1 | 71335083001 | 30 TABLET in 1 BOTTLE (71335-0830-1) | 30 tablet | 2022-02-09 | No | No | Historical |
| 71335-0830-2 | 71335083002 | 60 TABLET in 1 BOTTLE (71335-0830-2) | 60 tablet | 2022-02-09 | No | No | Historical |
| 71335-0830-3 | 71335083003 | 90 TABLET in 1 BOTTLE (71335-0830-3) | 90 tablet | 2022-02-09 | No | No | Historical |
| 71335-0830-4 | 71335083004 | 45 TABLET in 1 BOTTLE (71335-0830-4) | 45 tablet | 2022-02-09 | No | No | Historical |
| 71335-0830-5 | 71335083005 | 180 TABLET in 1 BOTTLE (71335-0830-5) | 180 tablet | 2022-02-09 | No | No | Historical |
| 71335-0830-6 | 71335083006 | 14 TABLET in 1 BOTTLE (71335-0830-6) | 14 tablet | 2022-02-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lamotrigine | Bryant Ranch Prepack | 2025-09-17 | HUMAN PRESCRIPTION DRUG LABEL | 102 |