Lamotrigine
- Product NDC
- 50090-5850
- 11-digit product format
- 500905850
- Labeler code
- 50090
- Product ID
- 50090-5850_f10b029f-722e-4c7e-93ea-c21e8c05c0f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Substance
- LAMOTRIGINE
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198428 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5850-0 | Lamotrigine | 60 in 1 BOTTLE | TABLET | 60 | | 14 |
| 50090-5850-1 | Lamotrigine | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5850 | LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231125_5a9575bb-230e-46ae-b58e-41554bad45eb.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 |
|---|
| 50090-5850-0 | 50090585000 | 60 TABLET in 1 BOTTLE (50090-5850-0) | 60 tablet | 2021-11-08 | 0000-00-00 | No | No | Current |
| 50090-5850-1 | 50090585001 | 30 TABLET in 1 BOTTLE (50090-5850-1) | 30 tablet | 2021-11-08 | 0000-00-00 | No | No | Current |