NDC 63629-7020

Lamotrigine Extended Release

Lamotrigine Extended Release

Lamotrigine Extended Release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Lamotrigine.

Product ID63629-7020_a25f0c76-e3f5-4260-bd84-9977684a8609
NDC63629-7020
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine Extended Release
Generic NameLamotrigine Extended Release
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA201791
Labeler NameBryant Ranch Prepack
Substance NameLAMOTRIGINE
Active Ingredient Strength300 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-7020-1

30 TABLET in 1 BOTTLE (63629-7020-1)
Marketing Start Date2016-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-7020-1 [63629702001]

Lamotrigine Extended Release TABLET
Marketing CategoryANDA
Application NumberANDA201791
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE300 mg/1

OpenFDA Data

SPL SET ID:b6acfef1-7d89-495a-a642-a47cc7d31e47
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098608

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Mood Stabilizer [EPC]
    • Anti-epileptic Agent [EPC]

    NDC Crossover Matching brand name "Lamotrigine Extended Release" or generic name "Lamotrigine Extended Release"

    NDCBrand NameGeneric Name
    49884-561Lamotrigine Extended Releaselamotrigine extended release
    49884-562Lamotrigine Extended Releaselamotrigine extended release
    49884-563Lamotrigine Extended Releaselamotrigine extended release
    49884-564Lamotrigine Extended Releaselamotrigine extended release
    49884-604Lamotrigine Extended Releaselamotrigine extended release
    49884-605Lamotrigine Extended Releaselamotrigine extended release
    52817-240Lamotrigine Extended Releaselamotrigine extended release
    52817-241Lamotrigine Extended Releaselamotrigine extended release
    52817-242Lamotrigine Extended Releaselamotrigine extended release
    52817-243Lamotrigine Extended Releaselamotrigine extended release
    63629-7020Lamotrigine Extended Releaselamotrigine extended release
    70518-0489Lamotrigine Extended Releaselamotrigine extended release
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