Lamotrigine
- Product NDC
- 68788-7223
- 11-digit product format
- 687887223
- Labeler code
- 68788
- Product ID
- 68788-7223_64f47b8c-9037-480b-a1e8-4b6d77ff859e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2018-07-26
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7223-3 | Lamotrigine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 9 |
| 68788-7223-6 | Lamotrigine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 9 |
| 68788-7223-9 | Lamotrigine | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7223 | LAMOTRIGINE TABLET [PREFERRED PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240607_09a0d30d-9b8f-4c76-8cdb-8492386b2254.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 |
|---|
| 68788-7223-3 | 68788722303 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-7223-3) | 30 tablet | 2018-07-26 | 0000-00-00 | No | No | Current |
| 68788-7223-6 | 68788722306 | 60 TABLET in 1 BOTTLE, PLASTIC (68788-7223-6) | 60 tablet | 2018-07-26 | 0000-00-00 | No | No | Current |
| 68788-7223-9 | 68788722309 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-7223-9) | 90 tablet | 2018-07-26 | 0000-00-00 | No | No | Current |