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NDC 65862-0361-99 Lamotrigine 5 mg/1 Details
Lamotrigine 5 mg/1
Lamotrigine is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is LAMOTRIGINE.
MedlinePlus Drug Summary
Lamotrigine extended-release (long-acting) tablets are used with other medications to treat certain types of seizures in patients who have epilepsy. All types of lamotrigine tablets (tablets, orally disintegrating tablets, and chewable tablets) other than the extended-release tablets are used alone or with other medications to treat seizures in people who have epilepsy or Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). All types of lamotrigine tablets other than the extended-release tablets are also used to increase the time between episodes of depression, mania (frenzied or abnormally excited mood), and other abnormal moods in patients with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Lamotrigine has not been shown to be effective when people experience the actual episodes of depression or mania, so other medications must be used to help people recover from these episodes. Lamotrigine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 65862-0361-99Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lamotrigine
Product Information
| NDC | 65862-0361 |
|---|---|
| Product ID | 65862-361_c280a9e2-877e-42b3-bc86-f8eb582f296d |
| Associated GPIs | 72600040000510 |
| GCN Sequence Number | 021935 |
| GCN Sequence Number Description | lamotrigine TB CHW DSP 5 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 64323 |
| HICL Sequence Number | 007378 |
| HICL Sequence Number Description | LAMOTRIGINE |
| Brand/Generic | Generic |
| Proprietary Name | Lamotrigine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lamotrigine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LAMOTRIGINE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | 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] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090401 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0361-99 (65862036199)
| NDC Package Code | 65862-361-99 |
|---|---|
| Billing NDC | 65862036199 |
| Package | 1000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-99) |
| Marketing Start Date | 2009-11-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |