Lamotrigine
- Product NDC
- 0904-7008
- 11-digit product format
- 009047008
- Labeler code
- 0904
- Product ID
- 0904-7008_32527cb0-9b5e-4757-b11d-068cbd861a02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Substance
- LAMOTRIGINE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 198427, 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7008-61 | Lamotrigine | 1 in 1 BLISTER PACK | TABLET | 1 | | 10 |
| 0904-7008-61 | Lamotrigine | 100 in 1 CARTON | TABLET | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7008 | LAMOTRIGINE TABLET [MAJOR PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241108_12e0be85-0961-4fe0-b973-83251ecf0f65.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 |
|---|
| 0904-7008-61 | 00904700861 | 100 BLISTER PACK in 1 CARTON (0904-7008-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2009-01-27 | 0000-00-00 | No | No | Current |