NDC 0093-0463

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Lamotrigine.

Product ID0093-0463_0cd46210-5b94-4c22-a312-d26428f00e8d
NDC0093-0463
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-07-22
Marketing End Date2019-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA076388
Labeler NameTeva Pharmaceuticals USA, 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

Packaging

NDC 0093-0463-01

100 TABLET in 1 BOTTLE (0093-0463-01)
Marketing Start Date2008-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0463-05 [00093046305]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA076388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-22
Marketing End Date2018-08-31

NDC 0093-0463-19 [00093046319]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA076388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-19
Marketing End Date2014-03-04

NDC 0093-0463-83 [00093046383]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA076388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-16
Marketing End Date2009-12-22

NDC 0093-0463-93 [00093046393]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA076388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-19
Marketing End Date2014-03-04

NDC 0093-0463-01 [00093046301]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA076388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-22
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE100 mg/1

OpenFDA Data

SPL SET ID:14799df4-c425-4946-9168-9028c1f2e571
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198427
  • 282401
  • 198428
  • 198429
  • UPC Code
  • 0300937247067
  • 0300930039010
  • 0300937248064
  • 0300930463013
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    67877-165LamotrigineLamotrigine
    67877-164LamotrigineLamotrigine
    67877-166LamotrigineLamotrigine
    67877-167LamotrigineLamotrigine
    68084-319LamotrigineLamotrigine
    68084-318LamotrigineLamotrigine
    68084-810LamotrigineLamotrigine
    68151-4249LamotrigineLamotrigine
    68382-007LamotrigineLamotrigine
    68382-008LamotrigineLamotrigine
    68382-108LamotrigineLamotrigine
    68382-009LamotrigineLamotrigine
    68382-109LamotrigineLamotrigine
    68382-011LamotrigineLamotrigine
    68382-006LamotrigineLamotrigine
    68382-010LamotrigineLamotrigine
    68462-244LamotrigineLamotrigine
    68462-246LamotrigineLamotrigine
    68462-245LamotrigineLamotrigine
    68462-229LamotrigineLamotrigine
    68462-228LamotrigineLamotrigine
    68462-243LamotrigineLamotrigine
    68788-6868LamotrigineLamotrigine
    68788-6822LAMOTRIGINELAMOTRIGINE
    68788-7223LamotrigineLamotrigine
    68788-7278LAMOTRIGINELAMOTRIGINE
    68788-7168LamotrigineLamotrigine
    68788-7178LAMOTRIGINELAMOTRIGINE
    68788-9526LamotrigineLamotrigine
    69097-151LAMOTRIGINELAMOTRIGINE
    69097-149LAMOTRIGINELAMOTRIGINE
    69097-152LAMOTRIGINELAMOTRIGINE
    69097-148LAMOTRIGINELAMOTRIGINE
    69102-639LAMOTRIGINELAMOTRIGINE
    70518-0001LAMOTRIGINELAMOTRIGINE
    70518-1153LamotrigineLamotrigine
    70518-1479LamotrigineLamotrigine

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