Lamotrigine
- Product NDC
- 68382-980
- 11-digit product format
- 683820980
- Labeler code
- 68382
- Product ID
- 68382-980_f4f7fc12-39cf-4974-80b3-d077e503bb90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207763
- Marketing category
- ANDA
- Marketing start
- 2020-05-14
- Substance
- LAMOTRIGINE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 850087, 850091, 900156, 900164, 1098608, 1146690 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-980-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 7 |
| 68382-980-06 | Lamotrigine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 7 |
| 68382-980-16 | Lamotrigine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-980 | LAMOTRIGINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250529_eb436371-d188-4803-a864-07b90c357e57.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 |
|---|
| 68382-980-05 | 68382098005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-05) | | 2020-05-14 | 0000-00-00 | No | No | Current |
| 68382-980-06 | 68382098006 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-06) | | 2020-05-14 | 0000-00-00 | No | No | Current |
| 68382-980-16 | 68382098016 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-16) | | 2020-05-14 | 0000-00-00 | No | No | Current |
| 68382-980-77 | 68382098077 | 10 BLISTER PACK in 1 CARTON (68382-980-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-980-30) | 10 blister pack | 2020-05-14 | 0000-00-00 | No | No | Current |