NDC 0115-1529

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Lamotrigine.

Product ID0115-1529_1a655191-72bc-4478-875c-9abb66d15f81
NDC0115-1529
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2015-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA200828
Labeler NameImpax Generics
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 Through2019-12-31

Packaging

NDC 0115-1529-08

3 BLISTER PACK in 1 CARTON (0115-1529-08) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1529-15)
Marketing Start Date2015-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1529-15 [00115152915]

Lamotrigine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA200828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-09

NDC 0115-1529-08 [00115152908]

Lamotrigine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA200828
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-09

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE200 mg/1

OpenFDA Data

SPL SET ID:380bddae-5b31-4965-96de-97711d859d11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 252479
  • 198430
  • 252478
  • 103968
  • 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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