NDC 0173-0772

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 ID0173-0772_1a0d04ed-67ec-4e70-81fd-7b44b45a40d2
NDC0173-0772
Product TypeHuman Prescription Drug
Proprietary NameLAMICTAL ODT
Generic NameLamotrigine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2009-06-05
Marketing CategoryNDA / NDA
Application NumberNDA022251
Labeler NameGlaxoSmithKline LLC
Substance NameLAMOTRIGINE
Active Ingredient Strength25 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0173-0772-02

1 DOSE PACK in 1 CARTON (0173-0772-02) > 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK
Marketing Start Date2009-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0772-02 [00173077202]

LAMICTAL ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-05

NDC 0173-0772-62 [00173077262]

LAMICTAL ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022251
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-05
Marketing End Date2009-10-08

NDC 0173-0772-61 [00173077261]

LAMICTAL ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA022251
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-05
Marketing End Date2009-10-08

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE25 mg/1

OpenFDA Data

SPL SET ID:d7e3572d-56fe-4727-2bb4-013ccca22678
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0173-0772LAMICTAL ODTLAMICTAL ODT
    0173-0777LAMICTAL ODTLAMICTAL ODT
    0173-0780LAMICTAL ODTLAMICTAL ODT
    0173-0779LAMICTAL ODTLAMICTAL ODT
    0173-0778LAMICTAL ODTLAMICTAL ODT
    0173-0774LAMICTAL ODTLAMICTAL ODT
    0173-0776LAMICTAL ODTLAMICTAL ODT
    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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