LAMOTRIGINE
- Product NDC
- 51655-855
- 11-digit product format
- 516550855
- Labeler code
- 51655
- Product ID
- 51655-855_4bbc2e3f-4c7e-48ba-e063-6394a90a1efa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078947
- Marketing category
- ANDA
- Marketing start
- 2023-02-06
- 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 | 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-855-52 | LAMOTRIGINE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-855 | LAMOTRIGINE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20250101_f7587283-781b-e111-e053-6394a90ad4cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-855-52 | 51655085552 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-855-52) | 30 tablet | 2023-02-06 | No | No | Current |