lamotrigine
- Product NDC
- 46708-095
- 11-digit product format
- 467080095
- Labeler code
- 46708
- Product ID
- 46708-095_4ea08829-6e98-4a5f-97d0-da2d1ac96dc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine chewable dispersible
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA201168
- Marketing category
- ANDA
- Marketing start
- 2016-01-29
- Substance
- LAMOTRIGINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 311264, 311265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-095-30 | lamotrigine | 30 in 1 BOTTLE | TABLET, FOR SUSPENSION | 30 | | 3 |
| 46708-095-31 | lamotrigine | 100 in 1 BOTTLE | TABLET, FOR SUSPENSION | 100 | | 3 |
| 46708-095-91 | lamotrigine | 1000 in 1 BOTTLE | TABLET, FOR SUSPENSION | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-095 | LAMOTRIGINE (LAMOTRIGINE CHEWABLE DISPERSIBLE) TABLET, FOR SUSPENSION [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230119_ae6522d4-d824-44aa-afe0-70cdcbd845af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-095-30 | 46708009530 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-30) | 2016-01-29 | 0000-00-00 | No | No | Current |
| 46708-095-31 | 46708009531 | 100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31) | 2016-01-29 | 0000-00-00 | No | No | Current |
| 46708-095-91 | 46708009591 | 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-91) | 2016-01-29 | 0000-00-00 | No | No | Current |