LAMOTRIGINE
- Product NDC
- 68071-3607
- 11-digit product format
- 680713607
- Labeler code
- 68071
- Product ID
- 68071-3607_1bbbeda6-9835-6c1c-e063-6294a90ad1ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078947
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LAMOTRIGINE
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-3607-6 | LAMOTRIGINE | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3607 | LAMOTRIGINE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240627_1bbbe2a2-a9e8-8c13-e063-6394a90a9627.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 |
|---|
| 68071-3607-6 | 68071360706 | 60 TABLET in 1 BOTTLE (68071-3607-6) | 60 tablet | 2024-06-25 | No | No | Current |