NDC 68382-983

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Lamotrigine.

Product ID68382-983_11b431ca-e7f1-4ef2-b2d6-1be2294d09b2
NDC68382-983
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA207763
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameLAMOTRIGINE
Active Ingredient Strength250 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 68382-983-05

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-983-05)
Marketing Start Date2020-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-983-06 [68382098306]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 68382-983-77 [68382098377]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 68382-983-16 [68382098316]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 68382-983-30 [68382098330]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 68382-983-05 [68382098305]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE250 mg/1

OpenFDA Data

SPL SET ID:eb436371-d188-4803-a864-07b90c357e57
Manufacturer
UNII
UPC Code
  • 0036081000080

    • 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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