NDC 65084-461

Keppra XR

Levetiracetam

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

Product ID65084-461_194d444f-6e9a-46fb-a4d4-750f93dfc80e
NDC65084-461
Product TypeHuman Prescription Drug
Proprietary NameKeppra XR
Generic NameLevetiracetam
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-04-01
Marketing CategoryNDA / NDA
Application NumberNDA022285
Labeler NameMckesson Rxpak Inc
Substance NameLEVETIRACETAM
Active Ingredient Strength750 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65084-461-20

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (65084-461-20)
Marketing Start Date2014-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65084-461-20 [65084046120]

Keppra XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022285
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-15

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM750 mg/1

OpenFDA Data

SPL SET ID:750462e4-0053-496b-8692-cf9132482ed9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 807832
  • 847673
  • 846378
  • 807834

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    50474-598Keppra XRKeppra XR
    50474-599Keppra XRKeppra XR
    65084-460Keppra XRKeppra XR
    65084-461Keppra XRKeppra XR
    70518-2109Keppra XRKeppra XR
    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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