NDC 55648-273

Lamotrigine

Lamotrigine

Lamotrigine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Lamotrigine.

Product ID55648-273_ddc5823c-ca8f-4f63-9d7b-d54c82798452
NDC55648-273
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotrigine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA202498
Labeler NameWockhardt Limited
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-273-02

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55648-273-02)
Marketing Start Date2012-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-273-02 [55648027302]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202498
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-29
Inactivation Date2020-01-31

NDC 55648-273-04 [55648027304]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202498
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-29
Inactivation Date2020-01-31

NDC 55648-273-01 [55648027301]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202498
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE100 mg/1

OpenFDA Data

SPL SET ID:d3a8267b-979f-431d-baba-4ad3c5aa05e4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 900156
  • 900164
  • 850087
  • 850091
  • 1098608
  • UPC Code
  • 0364679271018
  • 0364679275023
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.