NDC 0228-1580

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Lamotrigine.

Product ID0228-1580_013f56e8-d352-4b94-9980-1c0f0f676e71
NDC0228-1580
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA200672
Labeler NameActavis Pharma, Inc.
Substance NameLAMOTRIGINE
Active Ingredient Strength300 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 0228-1580-03

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1580-03)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0228-1580-03 [00228158003]

Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-01

NDC 0228-1580-50 [00228158050]

Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-01
Marketing End Date2016-04-01

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE300 mg/1

OpenFDA Data

SPL SET ID:87beaf22-593d-4170-bb58-332c615ef90d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1146690
  • 1098608
  • 900164
  • 850087
  • 850091
  • 900156
  • UPC Code
  • 0302281638034
  • 0302281453033
  • 0302281422039
  • 0302281435039
  • 0302281410036
  • 0302281580036
  • 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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