NDC 70518-0049

LAMICTAL

Lamotrigine

LAMICTAL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Lamotrigine.

Product ID70518-0049_81b3a266-c01b-64a3-e053-2a91aa0a0f66
NDC70518-0049
Product TypeHuman Prescription Drug
Proprietary NameLAMICTAL
Generic NameLamotrigine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-12-09
Marketing CategoryNDA / NDA
Application NumberNDA020241
Labeler NameREMEDYREPACK INC.
Substance NameLAMOTRIGINE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0049-0

30 TABLET in 1 BLISTER PACK (70518-0049-0)
Marketing Start Date2016-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0049-0 [70518004900]

LAMICTAL TABLET
Marketing CategoryNDA
Application NumberNDA020241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-09
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE100 mg/1

OpenFDA Data

SPL SET ID:cfe008a1-c11e-4a40-b176-5f21e0eceaeb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105018
  • 198427
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    70518-0049LAMICTALLAMICTAL
    21695-223LAMICTALLAMICTAL
    21695-224LAMICTALLAMICTAL
    0173-0526LAMICTALLAMICTAL
    0173-0633LAMICTALLAMICTAL
    0173-0644LAMICTALLAMICTAL
    0173-0527LAMICTALLAMICTAL
    0173-0699LAMICTALLAMICTAL
    0173-0642LAMICTALLAMICTAL
    0173-0643LAMICTALLAMICTAL
    0173-0817LAMICTALLAMICTAL
    0173-0594LAMICTALLAMICTAL
    55289-410LAMICTALLAMICTAL
    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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