Lamotrigine
- Product NDC
- 16714-195
- 11-digit product format
- 167140195
- Labeler code
- 16714
- Product ID
- 16714-195_f6d6f71c-c94d-4bde-ac57-850998dad74f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar Rx LLC.
- Application
- ANDA077633
- Marketing category
- ANDA
- Marketing start
- 2021-11-17
- 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, 198428, 198429, 282401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-195-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-195 | LAMOTRIGINE TABLET [NORTHSTAR RX LLC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230406_aabc64fe-1f17-4140-81f2-7d4506db6c8b.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 |
|---|
| 16714-195-01 | 16714019501 | 100 TABLET in 1 BOTTLE (16714-195-01) | 100 tablet | 2021-11-17 | 0000-00-00 | No | No | Current |