NDC 40051-079

LEVETIRACETAM Extended-release

Levetiracetam

LEVETIRACETAM Extended-release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lotus Pharmaceutical Co., Ltd. Nantou Plant. The primary component is Levetiracetam.

Product ID40051-079_7c902b2c-edf6-4dd0-923f-c38f2c621733
NDC40051-079
Product TypeHuman Prescription Drug
Proprietary NameLEVETIRACETAM Extended-release
Generic NameLevetiracetam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA202095
Labeler NameLotus Pharmaceutical Co., Ltd. Nantou Plant
Substance NameLEVETIRACETAM
Active Ingredient Strength750 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 40051-079-11

60 TABLET in 1 BOTTLE (40051-079-11)
Marketing Start Date2016-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40051-079-11 [40051007911]

LEVETIRACETAM EXTENDED-RELEASE TABLET
Marketing CategoryANDA
Application NumberANDA202095
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-31
Marketing End Date2019-11-15

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM750 mg/1

OpenFDA Data

SPL SET ID:aeb36add-e083-49be-9c3c-e76593c70d61
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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