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NDC 68382-0007-16 Lamotrigine 50 mg/1 Details

Lamotrigine 50 mg/1

Lamotrigine is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. 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: 68382-0007-16
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lamotrigine

Product Information

NDC	68382-0007
Product ID	68382-007_6ab4eff7-1c04-465f-a752-63149bca1d36
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Lamotrigine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lamotrigine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	LAMOTRIGINE
Labeler Name	Zydus Pharmaceuticals USA Inc.
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	ANDA077633
Listing Certified Through	2024-12-31

Package

NDC 68382-0007-16 (68382000716)

Pricing Information	N/A
NDC Package Code	68382-007-16
Billing NDC	68382000716
Package	90 TABLET in 1 BOTTLE (68382-007-16)
Marketing Start Date	2009-01-27
NDC Exclude Flag	N