Lamotrigine
- Product NDC
- 55111-720
- 11-digit product format
- 551110720
- Labeler code
- 55111
- Product ID
- 55111-720_236437dc-fce9-b140-992c-b7822562eee5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA202383
- Marketing category
- ANDA
- Marketing start
- 2013-06-20
- Substance
- LAMOTRIGINE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 850087, 850091, 900156, 900164, 1098608, 1146690 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-720-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 29 |
| 55111-720-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 29 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-720 | LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED] | 27 | Current NDC, Legacy NDC, 2 package rows | 20210528_a69542ea-5b6f-15c1-9e7a-90ac839971d3.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 |
|---|
| 55111-720-05 | 55111072005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-720-05) | 2013-06-20 | 0000-00-00 | No | No | Current |
| 55111-720-30 | 55111072030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-720-30) | 2013-06-20 | 0000-00-00 | No | No | Current |