NDC 0173-0776

LAMICTAL ODT

Lamotrigine

LAMICTAL ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Lamotrigine.

• Product ID: 0173-0776_1a0d04ed-67ec-4e70-81fd-7b44b45a40d2
• NDC: 0173-0776
• Product Type: Human Prescription Drug
• Proprietary Name: LAMICTAL ODT
• Generic Name: Lamotrigine
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-05
• Marketing Category: NDA / NDA
• Application Number: NDA022251
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: LAMOTRIGINE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0173-0776-02

1 DOSE PACK in 1 CARTON (0173-0776-02) > 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK

• Marketing Start Date: 2009-06-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0776-02 [00173077602]

LAMICTAL ODT TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA022251
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-05

NDC 0173-0776-61 [00173077661]

LAMICTAL ODT TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA022251
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-06-05
• Marketing End Date: 2011-08-17

Drug Details

Active Ingredients

Ingredient	Strength
LAMOTRIGINE	100 mg/1

OpenFDA Data

• SPL SET ID: d7e3572d-56fe-4727-2bb4-013ccca22678
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • U3H27498KS
• RxNorm Concept Unique ID - RxCUI:
  • 103968
  • 751563
  • 849049
  • 751139
  • 311265
  • 311264
  • 851750
  • 851751
  • 851752
  • 282401
  • 851753
  • 753451
  • 108782
  • 198430
  • 201240
  • 849052
  • 849050
  • 849051
  • 252479
  • 851749
  • 851748
  • 795774
  • 795772
  • 795778
  • 105019
  • 105018
  • 542426
  • 198427
  • 252478
  • 206201
  • 201239
  • 349010
  • 198428
  • 198429
• UPC Code:
  • 0301730644602
  • 0301730699008
  • 0301730643605
  • 0301730527004
  • 0301730526007
  • 0301730642554

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0173-0772	LAMICTAL ODT	LAMICTAL ODT
0173-0777	LAMICTAL ODT	LAMICTAL ODT
0173-0780	LAMICTAL ODT	LAMICTAL ODT
0173-0779	LAMICTAL ODT	LAMICTAL ODT
0173-0778	LAMICTAL ODT	LAMICTAL ODT
0173-0774	LAMICTAL ODT	LAMICTAL ODT
0173-0776	LAMICTAL ODT	LAMICTAL ODT
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