Lamotrigine
- Product NDC
- 65841-684
- 11-digit product format
- 658410684
- Labeler code
- 65841
- Product ID
- 65841-684_c4eb074b-9cd4-4bcd-868c-473d9364061c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Substance
- LAMOTRIGINE
- Active strength
- 100 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 | 100 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65841-684-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 65841-684-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET | 500 | | 12 |
| 65841-684-10 | Lamotrigine | 1000 in 1 BOTTLE | TABLET | 1000 | | 12 |
| 65841-684-16 | Lamotrigine | 90 in 1 BOTTLE | TABLET | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-684 | LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS LIFESCIENCES LIMITED] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241204_0f2f7421-56d4-45d0-9d2d-dc1edaede039.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 |
|---|
| 65841-684-01 | 65841068401 | 100 TABLET in 1 BOTTLE (65841-684-01) | 100 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 65841-684-05 | 65841068405 | 500 TABLET in 1 BOTTLE (65841-684-05) | 500 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 65841-684-10 | 65841068410 | 1000 TABLET in 1 BOTTLE (65841-684-10) | 1000 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |
| 65841-684-16 | 65841068416 | 90 TABLET in 1 BOTTLE (65841-684-16) | 90 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |