Lamotrigine
- Product NDC
- 65862-362
- 11-digit product format
- 658620362
- Labeler code
- 65862
- Product ID
- 65862-362_743955c4-0ece-4619-8e3e-a9e0a51e9491
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA090401
- Marketing category
- ANDA
- Marketing start
- 2009-11-04
- 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
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 311264, 311265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-362-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 28 |
| 65862-362-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET, CHEWABLE | 500 | | 28 |
| 65862-362-10 | Lamotrigine | 10 in 1 CARTON | TABLET, CHEWABLE | 10 | | 28 |
| 65862-362-10 | Lamotrigine | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | | 28 |
| 65862-362-81 | Lamotrigine | 8000 in 1 BOTTLE | TABLET, CHEWABLE | 8000 | | 28 |
| 65862-362-99 | Lamotrigine | 1000 in 1 BOTTLE | TABLET, CHEWABLE | 1000 | | 28 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-362 | LAMOTRIGINE TABLET, CHEWABLE [AUROBINDO PHARMA LIMITED] | 25 | Current NDC, Legacy NDC, 6 package rows | 20231218_e08920c2-04a3-4fb5-acc5-0af3140f82e9.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 |
|---|
| 65862-362-01 | 65862036201 | 100 TABLET, CHEWABLE in 1 BOTTLE (65862-362-01) | | 2009-11-04 | 0000-00-00 | No | No | Current |
| 65862-362-05 | 65862036205 | 500 TABLET, CHEWABLE in 1 BOTTLE (65862-362-05) | | 2009-11-04 | 0000-00-00 | No | No | Current |
| 65862-362-10 | 65862036210 | 10 BLISTER PACK in 1 CARTON (65862-362-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 10 blister pack | 2009-11-04 | 0000-00-00 | No | No | Current |
| 65862-362-81 | 65862036281 | 8000 TABLET, CHEWABLE in 1 BOTTLE (65862-362-81) | | 2009-11-04 | 0000-00-00 | No | No | Current |
| 65862-362-99 | 65862036299 | 1000 TABLET, CHEWABLE in 1 BOTTLE (65862-362-99) | | 2009-11-04 | 0000-00-00 | No | No | Current |