Lamotrigine
- Product NDC
- 68382-006
- 11-digit product format
- 683820006
- Labeler code
- 68382
- Product ID
- 68382-006_277200d5-a863-4411-8c1b-aac8d7fde6a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 198429, 199322, 249329, 282401, 311264, 311265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-006 | LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS PHARMACEUTICALS USA INC.] | 28 | Current NDC, Legacy NDC, 5 package rows | 20250510_e849033b-a3bc-408e-88de-7cd1d2660949.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-006-01 | 68382000601 | 100 TABLET in 1 BOTTLE (68382-006-01) | 100 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 68382-006-05 | 68382000605 | 500 TABLET in 1 BOTTLE (68382-006-05) | 500 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 68382-006-10 | 68382000610 | 1000 TABLET in 1 BOTTLE (68382-006-10) | 1000 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 68382-006-11 | 68382000611 | 25 TABLET in 1 BOTTLE (68382-006-11) | 25 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 68382-006-16 | 68382000616 | 90 TABLET in 1 BOTTLE (68382-006-16) | 90 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |