NDC 50474-002

Keppra

Levetiracetam

Keppra is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Ucb, Inc.. The primary component is Levetiracetam.

Product ID50474-002_1a42ebe3-0b83-48c2-a95b-a547460f6a39
NDC50474-002
Product TypeHuman Prescription Drug
Proprietary NameKeppra
Generic NameLevetiracetam
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-08-23
Marketing CategoryNDA / NDA
Application NumberNDA021872
Labeler NameUCB, Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength100 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50474-002-63

10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2006-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50474-002-63 [50474000263]

Keppra INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA021872
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-08-23

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM100 mg/mL

OpenFDA Data

SPL SET ID:c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 647123
  • 647121

    • 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
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