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 ID0173-0757_6279d63d-7f3d-43a4-ab63-9fda79c126a2
NDC0173-0757
Product TypeHuman Prescription Drug
Proprietary NameLAMICTAL XR
Generic NameLamotrigine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-07-06
Marketing CategoryNDA / NDA
Application NumberNDA022115
Labeler NameGlaxoSmithKline LLC
Substance NameLAMOTRIGINE
Active Ingredient Strength200 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0173-0757-00

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0757-00)
Marketing Start Date2009-07-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0757-00 [00173075700]

LAMICTAL XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-06

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE200 mg/1

OpenFDA Data

SPL SET ID:3e2c9a35-6a39-41d7-ad84-3c0bb8894b09
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0173-0758LAMICTAL XRLAMICTAL XR
    0173-0754LAMICTAL XRLAMICTAL XR
    0173-0757LAMICTAL XRLAMICTAL XR
    0173-0756LAMICTAL XRLAMICTAL XR
    0173-0759LAMICTAL XRLAMICTAL XR
    0173-0781LAMICTAL XRLAMICTAL XR
    0173-0760LAMICTAL XRLAMICTAL XR
    0173-0761LAMICTAL XRLAMICTAL XR
    0173-0755LAMICTAL XRLAMICTAL XR
    0093-0039LamotrigineLamotrigine
    0093-0132LamotrigineLamotrigine
    0093-0463LamotrigineLamotrigine
    0093-0688LamotrigineLamotrigine
    0093-7247LamotrigineLamotrigine
    0093-7248LamotrigineLamotrigine
    0115-1526LamotrigineLAMOTRIGINE
    0115-1527LamotrigineLAMOTRIGINE
    0115-1528LamotrigineLAMOTRIGINE
    0115-1529LamotrigineLAMOTRIGINE
    0115-9939LamotrigineLAMOTRIGINE
    0115-9940LamotrigineLAMOTRIGINE
    0115-9941LamotrigineLAMOTRIGINE

    Trademark Results [LAMICTAL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LAMICTAL
    LAMICTAL
    73742475 1552463 Live/Registered
    BURROUGHS WELLCOME CO.
    1988-07-27

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