NDC 70518-0489

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 Remedyrepack Inc.. The primary component is Lamotrigine.

Product ID70518-0489_5e88776b-1c60-09a9-e053-2991aa0a07e9
NDC70518-0489
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine Extended Release
Generic NameLamotrigine Extended Release
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-05-10
Marketing CategoryANDA / ANDA
Application NumberANDA201791
Labeler NameREMEDYREPACK INC.
Substance NameLAMOTRIGINE
Active Ingredient Strength50 mg/1
Pharm ClassesDecreased Centr
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0489-0

30 TABLET in 1 BLISTER PACK (70518-0489-0)
Marketing Start Date2017-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0489-0 [70518048900]

Lamotrigine Extended Release TABLET
Marketing CategoryANDA
Application NumberANDA201791
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-08
Marketing End Date2020-04-06

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE50 mg/1

OpenFDA Data

SPL SET ID:dda197c4-3255-40d7-8950-5d4e5416edfd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 850091

    • 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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