Lamotrigine
- Product NDC
- 71335-1110
- 11-digit product format
- 713351110
- Labeler code
- 71335
- Product ID
- 71335-1110_e0a776b5-f06c-4596-b44d-3aa2be05e860
- 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
- 150 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198428 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1110-1 | 71335111001 | 60 TABLET in 1 BOTTLE (71335-1110-1) | 60 tablet | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1110-2 | 71335111002 | 30 TABLET in 1 BOTTLE (71335-1110-2) | 30 tablet | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1110-3 | 71335111003 | 90 TABLET in 1 BOTTLE (71335-1110-3) | 90 tablet | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1110-4 | 71335111004 | 120 TABLET in 1 BOTTLE (71335-1110-4) | 120 tablet | 2022-02-09 | 0000-00-00 | No | No | Current |
| 71335-1110-5 | 71335111005 | 180 TABLET in 1 BOTTLE (71335-1110-5) | 180 tablet | 2022-02-09 | 0000-00-00 | No | No | Current |