NDC 65084-458

Keppra

Levetiracetam

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

Product ID65084-458_ef7f5ccc-c93b-47b3-a915-3e76610073a8
NDC65084-458
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 NameMckesson Rxpak Inc
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65084-458-36

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65084-458-36)
Marketing Start Date2014-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65084-458-36 [65084045836]

Keppra TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021035
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-15

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:d317020c-0850-4a5b-b344-74ad10b0b089
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261336
  • 311290
  • 284391
  • 311289
  • 387003
  • 630807

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • 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
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