NDC 0173-0757

LAMICTAL XR

Lamotrigine

LAMICTAL XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Lamotrigine.

• Product ID: 0173-0757_6279d63d-7f3d-43a4-ab63-9fda79c126a2
• NDC: 0173-0757
• Product Type: Human Prescription Drug
• Proprietary Name: LAMICTAL XR
• Generic Name: Lamotrigine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-06
• Marketing Category: NDA / NDA
• Application Number: NDA022115
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: LAMOTRIGINE
• Active Ingredient Strength: 200 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: 2022-12-31

Packaging

NDC 0173-0757-00

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0757-00)

• Marketing Start Date: 2009-07-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0757-00 [00173075700]

LAMICTAL XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022115
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-06

Drug Details

Active Ingredients

Ingredient	Strength
LAMOTRIGINE	200 mg/1

OpenFDA Data

• SPL SET ID: 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • U3H27498KS
• RxNorm Concept Unique ID - RxCUI:
  • 1146690
  • 1146692
  • 900866
  • 900865
  • 900890
  • 900891
  • 900984
  • 1098608
  • 900164
  • 900165
  • 850087
  • 850091
  • 900983
  • 900157
  • 900156
  • 1098610
  • 900169
  • 900145
• UPC Code:
  • 0301730755001
  • 0301730757005
  • 0301730761002
  • 0301730781000
  • 0301730756008
  • 0301730754004

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0173-0758	LAMICTAL XR	LAMICTAL XR
0173-0754	LAMICTAL XR	LAMICTAL XR
0173-0757	LAMICTAL XR	LAMICTAL XR
0173-0756	LAMICTAL XR	LAMICTAL XR
0173-0759	LAMICTAL XR	LAMICTAL XR
0173-0781	LAMICTAL XR	LAMICTAL XR
0173-0760	LAMICTAL XR	LAMICTAL XR
0173-0761	LAMICTAL XR	LAMICTAL XR
0173-0755	LAMICTAL XR	LAMICTAL XR
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