Lamotrigine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Lamotrigine.
| Product ID | 68382-981_11b431ca-e7f1-4ef2-b2d6-1be2294d09b2 |
| NDC | 68382-981 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Lamotrigine |
| Generic Name | Lamotrigine |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207763 |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Substance Name | LAMOTRIGINE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm 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 | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2020-05-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207763 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA |
| Application Number | ANDA207763 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA |
| Application Number | ANDA207763 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA |
| Application Number | ANDA207763 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| Marketing Category | ANDA |
| Application Number | ANDA207763 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-14 |
| Ingredient | Strength |
|---|---|
| LAMOTRIGINE | 100 mg/1 |
| SPL SET ID: | eb436371-d188-4803-a864-07b90c357e57 |
| Manufacturer | |
| UNII | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-0039 | Lamotrigine | Lamotrigine |
| 0093-0132 | Lamotrigine | Lamotrigine |
| 0093-0463 | Lamotrigine | Lamotrigine |
| 0093-0688 | Lamotrigine | Lamotrigine |
| 0093-7247 | Lamotrigine | Lamotrigine |
| 0093-7248 | Lamotrigine | Lamotrigine |
| 0115-1526 | Lamotrigine | LAMOTRIGINE |
| 0115-1527 | Lamotrigine | LAMOTRIGINE |
| 0115-1528 | Lamotrigine | LAMOTRIGINE |
| 0115-1529 | Lamotrigine | LAMOTRIGINE |
| 0115-9939 | Lamotrigine | LAMOTRIGINE |
| 0115-9940 | Lamotrigine | LAMOTRIGINE |
| 0115-9941 | Lamotrigine | LAMOTRIGINE |
| 67877-165 | Lamotrigine | Lamotrigine |
| 67877-164 | Lamotrigine | Lamotrigine |
| 67877-166 | Lamotrigine | Lamotrigine |
| 67877-167 | Lamotrigine | Lamotrigine |
| 68084-319 | Lamotrigine | Lamotrigine |
| 68084-318 | Lamotrigine | Lamotrigine |
| 68084-810 | Lamotrigine | Lamotrigine |
| 68151-4249 | Lamotrigine | Lamotrigine |
| 68382-007 | Lamotrigine | Lamotrigine |
| 68382-008 | Lamotrigine | Lamotrigine |
| 68382-108 | Lamotrigine | Lamotrigine |
| 68382-009 | Lamotrigine | Lamotrigine |
| 68382-109 | Lamotrigine | Lamotrigine |
| 68382-011 | Lamotrigine | Lamotrigine |
| 68382-006 | Lamotrigine | Lamotrigine |
| 68382-010 | Lamotrigine | Lamotrigine |
| 68462-244 | Lamotrigine | Lamotrigine |
| 68462-246 | Lamotrigine | Lamotrigine |
| 68462-245 | Lamotrigine | Lamotrigine |
| 68462-229 | Lamotrigine | Lamotrigine |
| 68462-228 | Lamotrigine | Lamotrigine |
| 68462-243 | Lamotrigine | Lamotrigine |
| 68788-6868 | Lamotrigine | Lamotrigine |
| 68788-6822 | LAMOTRIGINE | LAMOTRIGINE |
| 68788-7223 | Lamotrigine | Lamotrigine |
| 68788-7278 | LAMOTRIGINE | LAMOTRIGINE |
| 68788-7168 | Lamotrigine | Lamotrigine |
| 68788-7178 | LAMOTRIGINE | LAMOTRIGINE |
| 68788-9526 | Lamotrigine | Lamotrigine |
| 69097-151 | LAMOTRIGINE | LAMOTRIGINE |
| 69097-149 | LAMOTRIGINE | LAMOTRIGINE |
| 69097-152 | LAMOTRIGINE | LAMOTRIGINE |
| 69097-148 | LAMOTRIGINE | LAMOTRIGINE |
| 69102-639 | LAMOTRIGINE | LAMOTRIGINE |
| 70518-0001 | LAMOTRIGINE | LAMOTRIGINE |
| 70518-1153 | Lamotrigine | Lamotrigine |
| 70518-1479 | Lamotrigine | Lamotrigine |