NDC 65841-685

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Lamotrigine.

Product ID65841-685_05041788-398f-4cd7-b09d-cb709778af87
NDC65841-685
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-01-27
Marketing CategoryANDA / ANDA
Application NumberANDA077633
Labeler NameZydus Lifesciences Limited
Substance NameLAMOTRIGINE
Active Ingredient Strength150 mg/1
Pharm ClassesAnti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-685-05

500 TABLET in 1 BOTTLE (65841-685-05)
Marketing Start Date2009-01-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-685-14 [65841068514]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA077633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-27

NDC 65841-685-05 [65841068505]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA077633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-27

NDC 65841-685-16 [65841068516]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA077633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-27

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE150 mg/1

OpenFDA Data

SPL SET ID:0f2f7421-56d4-45d0-9d2d-dc1edaede039
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198427
  • 199322
  • 311264
  • 249329
  • 311265
  • 282401
  • 198428
  • 198429
  • UPC Code
  • 0365841687057
  • 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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