Lamotrigine
- Product NDC
- 50228-321
- 11-digit product format
- 502280321
- Labeler code
- 50228
- Product ID
- 50228-321_ec9440ec-0301-59bb-e053-2a95a90afe94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA206382
- Marketing category
- ANDA
- Marketing start
- 2015-11-30
- 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 | 103968, 198430, 252478, 252479 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-321-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | | 7 |
| 50228-321-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-321 | LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [SCIEGEN PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20221104_de700ac1-4048-467e-abb1-238953261a97.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 |
|---|
| 50228-321-01 | 50228032101 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-321-01) | 2015-11-30 | 0000-00-00 | No | No | Current |
| 50228-321-30 | 50228032130 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-321-30) | 2015-11-30 | 0000-00-00 | No | No | Current |