NDC 76519-1151

LAMOTRIGINE

Lamotrigine

LAMOTRIGINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Lamotrigine.

Product ID76519-1151_839e9c4c-bff9-fda2-e053-2a91aa0a9be4
NDC76519-1151
Product TypeHuman Prescription Drug
Proprietary NameLAMOTRIGINE
Generic NameLamotrigine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-16
Marketing CategoryANDA / ANDA
Application NumberANDA077783
Labeler NameH. J. Harkins Company 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 76519-1151-1

100 TABLET in 1 CONTAINER (76519-1151-1)
Marketing Start Date2017-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1151-3 [76519115103]

LAMOTRIGINE TABLET
Marketing CategoryANDA
Application NumberANDA077783
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-16

NDC 76519-1151-9 [76519115109]

LAMOTRIGINE TABLET
Marketing CategoryANDA
Application NumberANDA077783
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-16

NDC 76519-1151-6 [76519115106]

LAMOTRIGINE TABLET
Marketing CategoryANDA
Application NumberANDA077783
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-16

NDC 76519-1151-1 [76519115101]

LAMOTRIGINE TABLET
Marketing CategoryANDA
Application NumberANDA077783
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-16

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE100 mg/1

OpenFDA Data

SPL SET ID:60f3672f-4ca3-17ea-e053-2991aa0a6b5e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198427
  • 282401
  • 198429
  • Pharmacological Class

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