NDC 0781-5125

Lamotrigine

Lamotrigine

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

Product ID0781-5125_b0406e06-b384-4f8a-9c2c-e8dba2389c42
NDC0781-5125
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA078645
Labeler NameSandoz Inc
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0781-5125-01

100 TABLET in 1 BOTTLE (0781-5125-01)
Marketing Start Date2010-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5125-60 [00781512560]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA078645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-05
Marketing End Date2010-01-05

NDC 0781-5125-13 [00781512513]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA078645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-05
Marketing End Date2010-01-05

NDC 0781-5125-10 [00781512510]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA078645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-05
Marketing End Date2010-01-05

NDC 0781-5125-31 [00781512531]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA078645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-05
Marketing End Date2010-01-05

NDC 0781-5125-01 [00781512501]

Lamotrigine TABLET
Marketing CategoryANDA
Application NumberANDA078645
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-05
Marketing End Date2010-01-05

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE200 mg/1

OpenFDA Data

SPL SET ID:19c64c47-0410-4c7d-bad8-dbcd8fb94d1a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198427
  • 282401
  • 751563
  • 198428
  • 198429
  • 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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