NDC 55289-097

Keppra

Levetiracetam

Keppra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Levetiracetam.

Product ID55289-097_7bd56edd-9372-303b-e053-2991aa0ab3c6
NDC55289-097
Product TypeHuman Prescription Drug
Proprietary NameKeppra
Generic NameLevetiracetam
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-04-24
Marketing CategoryNDA / NDA
Application NumberNDA021035
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-097-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-097-30)
Marketing Start Date2009-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-097-30 [55289009730]

Keppra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-05

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:656756de-2404-4845-a8a7-c0ffa2d61c90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261336
  • 311289
    • UPC Code
  • 0355289097303

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    NDC Crossover Matching brand name "Keppra" or generic name "Levetiracetam"

    NDCBrand NameGeneric Name
    21695-070KeppraKeppra
    50474-595KeppraKeppra
    50474-597KeppraKeppra
    50474-002KeppraKeppra
    50474-594KeppraKeppra
    50474-001KeppraKeppra
    50474-596KeppraKeppra
    55289-097KeppraKeppra
    65084-457KeppraKeppra
    65084-458KeppraKeppra
    65084-459KeppraKeppra
    0054-0224LevetiracetamLevetiracetam
    0121-0799LevetiracetamLEVETIRACETAM
    0121-1598LevetiracetamLEVETIRACETAM
    0121-2397LevetiracetamLEVETIRACETAM
    0121-4799LevetiracetamLEVETIRACETAM
    0121-4802LEVETIRACETAMLEVETIRACETAM
    0143-9574LevetiracetamLevetiracetam
    0143-9673LevetiracetamLevetiracetam
    0228-2167LevetiracetamLevetiracetam
    0378-5613Levetiracetamlevetiracetam
    0378-5615Levetiracetamlevetiracetam
    0378-5617Levetiracetamlevetiracetam

    Trademark Results [Keppra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KEPPRA
    KEPPRA
    75686195 2454519 Live/Registered
    UCB BIOPHARMA SPRL
    1999-04-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.