Lamotrigine
- Product NDC
- 62332-038
- 11-digit product format
- 623320038
- Labeler code
- 62332
- Product ID
- 62332-038_3a44ccc7-087b-4201-a4ea-2d9c9b3195b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA090607
- Marketing category
- ANDA
- Marketing start
- 2018-02-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 100 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-038-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
| 62332-038-31 | Lamotrigine | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 62332-038-71 | Lamotrigine | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
| 62332-038-91 | Lamotrigine | 1000 in 1 BOTTLE | TABLET | 1000 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-038 | LAMOTRIGINE TABLET [ALEMBIC PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20241212_60958229-5b5f-49e2-97f4-a8722138f7ce.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-038-30 | 62332003830 | 30 TABLET in 1 BOTTLE (62332-038-30) | 30 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |
| 62332-038-31 | 62332003831 | 100 TABLET in 1 BOTTLE (62332-038-31) | 100 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |
| 62332-038-71 | 62332003871 | 500 TABLET in 1 BOTTLE (62332-038-71) | 500 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |
| 62332-038-91 | 62332003891 | 1000 TABLET in 1 BOTTLE (62332-038-91) | 1000 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |