Lamotrigine
- Product NDC
- 63187-487
- 11-digit product format
- 631870487
- Labeler code
- 63187
- Product ID
- 63187-487_18af9e56-f14e-4e59-b3cc-ad6e40d4bd57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- Substance
- LAMOTRIGINE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-487-30 | Lamotrigine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
| 63187-487-60 | Lamotrigine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 5 |
| 63187-487-72 | Lamotrigine | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 5 |
| 63187-487-90 | Lamotrigine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-487 | LAMOTRIGINE TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20220426_b94ae2e4-e276-40c1-bc25-da980194fc99.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 |
|---|
| 63187-487-30 | 63187048730 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-487-30) | 30 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-487-60 | 63187048760 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-487-60) | 60 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-487-72 | 63187048772 | 120 TABLET in 1 BOTTLE, PLASTIC (63187-487-72) | 120 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-487-90 | 63187048790 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-487-90) | 90 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |