Lamotrigine
- Product NDC
- 69918-370
- 11-digit product format
- 699180370
- Labeler code
- 69918
- Product ID
- 69918-370_4caaabfb-8886-4e0d-b2f2-d8102d8a55e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nordic Pharma, Inc.
- Application
- ANDA214124
- Marketing category
- ANDA
- Marketing start
- 2022-02-14
- 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 | 103968, 198430, 252478, 252479 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69918-370-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69918-370 | LAMOTRIGINE TABLET [NORDIC PHARMA, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250430_67cf961e-02b9-4a99-944f-43a55df6a544.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 |
|---|
| 69918-370-30 | 69918037030 | 30 TABLET in 1 BOTTLE (69918-370-30) | 30 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |