Lamotrigine
- Product NDC
- 72888-028
- 11-digit product format
- 728880028
- Labeler code
- 72888
- Product ID
- 72888-028_43efd790-7e05-d37a-e063-6294a90a4156
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advagen Pharma Limited
- Application
- ANDA078625
- Marketing category
- ANDA
- Marketing start
- 2021-10-29
- 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
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 198428, 198429, 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-028-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 72888-028-60 | Lamotrigine | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-028 | LAMOTRIGINE TABLET [ADVAGEN PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230307_4ca9d713-ab63-48bf-9386-29301a842e60.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 |
|---|
| 72888-028-05 | 72888002805 | 500 TABLET in 1 BOTTLE (72888-028-05) | 500 tablet | 2021-10-29 | 0000-00-00 | No | No | Current |
| 72888-028-60 | 72888002860 | 60 TABLET in 1 BOTTLE (72888-028-60) | 60 tablet | 2021-10-29 | 0000-00-00 | No | No | Current |