NDC 65841-682

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Lamotrigine.

• Product ID: 65841-682_05041788-398f-4cd7-b09d-cb709778af87
• NDC: 65841-682
• Product Type: Human Prescription Drug
• Proprietary Name: Lamotrigine
• Generic Name: Lamotrigine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-01-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077633
• Labeler Name: Zydus Lifesciences Limited
• Substance Name: LAMOTRIGINE
• Active Ingredient Strength: 25 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

Packaging

NDC 65841-682-01

100 TABLET in 1 BOTTLE (65841-682-01)

• Marketing Start Date: 2009-01-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65841-682-10 [65841068210]

Lamotrigine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077633
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-01-27

NDC 65841-682-01 [65841068201]

Lamotrigine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077633
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-01-27

NDC 65841-682-16 [65841068216]

Lamotrigine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077633
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-01-27

NDC 65841-682-05 [65841068205]

Lamotrigine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077633
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-01-27

NDC 65841-682-11 [65841068211]

Lamotrigine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077633
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-01-27

Drug Details

Active Ingredients

Ingredient	Strength
LAMOTRIGINE	25 mg/1

OpenFDA Data

• SPL SET ID: 0f2f7421-56d4-45d0-9d2d-dc1edaede039
• Manufacturer:
  • Cadila Healthcare Limited
• UNII:
  • U3H27498KS
• RxNorm Concept Unique ID - RxCUI:
  • 198427
  • 199322
  • 311264
  • 249329
  • 311265
  • 282401
  • 198428
  • 198429
• UPC Code:
  • 0365841687057

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Mood Stabilizer [EPC]
• Anti-epileptic Agent [EPC]

NDC Crossover Matching brand name "Lamotrigine" or generic name "Lamotrigine"

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