NDC 52817-111

levetiracetam extended-release

Levetiracetam

levetiracetam extended-release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Trupharma, Llc. The primary component is Levetiracetam.

Product ID52817-111_6138a3f1-9a19-366f-e053-2a91aa0aa8d0
NDC52817-111
Product TypeHuman Prescription Drug
Proprietary Namelevetiracetam extended-release
Generic NameLevetiracetam
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA201464
Labeler NameTrupharma, LLC
Substance NameLEVETIRACETAM
Active Ingredient Strength750 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52817-111-32

300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-111-32)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52817-111-60 [52817011160]

levetiracetam extended-release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201464
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-01

NDC 52817-111-32 [52817011132]

levetiracetam extended-release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201464
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-01

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM750 mg/1

OpenFDA Data

SPL SET ID:61109881-516d-4881-a831-5c19ff4faf33
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 807832
  • 846378

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    NDC Crossover Matching brand name "levetiracetam extended-release" or generic name "Levetiracetam"

    NDCBrand NameGeneric Name
    10370-195levetiracetam extended-releaselevetiracetam extended-release
    10370-214levetiracetam extended-releaselevetiracetam extended-release
    35208-031Levetiracetam Extended-releaseLevetiracetam Extended-release
    35208-032Levetiracetam Extended-releaseLevetiracetam Extended-release
    40051-079LEVETIRACETAM Extended-releaseLEVETIRACETAM Extended-release
    40051-332LEVETIRACETAM Extended-releaseLEVETIRACETAM Extended-release
    52817-111levetiracetam extended-releaselevetiracetam extended-release
    52817-110levetiracetam extended-releaselevetiracetam extended-release
    60429-349Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    60429-350Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    50228-190Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    50228-189Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    55488-0519LEVETIRACETAM Extended-releaseLEVETIRACETAM Extended-release
    0054-0224LevetiracetamLevetiracetam
    0121-0799LevetiracetamLEVETIRACETAM
    0121-1598LevetiracetamLEVETIRACETAM
    0121-2397LevetiracetamLEVETIRACETAM
    0121-4799LevetiracetamLEVETIRACETAM
    0121-4802LEVETIRACETAMLEVETIRACETAM
    0143-9574LevetiracetamLevetiracetam
    0143-9673LevetiracetamLevetiracetam
    0228-2167LevetiracetamLevetiracetam
    0378-5613Levetiracetamlevetiracetam
    0378-5615Levetiracetamlevetiracetam
    0378-5617Levetiracetamlevetiracetam
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