NDC 46708-095

lamotrigine

Lamotrigine Chewable Dispersible

lamotrigine is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Lamotrigine.

Product ID46708-095_7226f271-a3f0-4276-a130-f0fcfd1d91e7
NDC46708-095
Product TypeHuman Prescription Drug
Proprietary Namelamotrigine
Generic NameLamotrigine Chewable Dispersible
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2016-01-29
Marketing CategoryANDA / ANDA
Application NumberANDA201168
Labeler NameAlembic Pharmaceuticals Limited
Substance NameLAMOTRIGINE
Active Ingredient Strength5 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 46708-095-30

30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-30)
Marketing Start Date2016-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-095-91 [46708009591]

lamotrigine TABLET, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA201168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-29

NDC 46708-095-31 [46708009531]

lamotrigine TABLET, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA201168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-29

NDC 46708-095-30 [46708009530]

lamotrigine TABLET, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA201168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-29

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE5 mg/1

OpenFDA Data

SPL SET ID:ae6522d4-d824-44aa-afe0-70cdcbd845af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311265
  • 311264
  • UPC Code
  • 0346708096304
  • 0346708095307
  • 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 Chewable Dispersible"

    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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