NDC 43485-104

Spritam

Levetiracetam

Spritam is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Aprecia Pharmaceuticals, Llc. The primary component is Levetiracetam.

Product ID43485-104_15ec15e4-e891-4ef7-bd05-99d43e61124e
NDC43485-104
Product TypeHuman Prescription Drug
Proprietary NameSpritam
Generic NameLevetiracetam
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2016-02-05
Marketing CategoryNDA / NDA
Application NumberNDA207958
Labeler NameAprecia Pharmaceuticals, LLC
Substance NameLEVETIRACETAM
Active Ingredient Strength1000 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 43485-104-60

60 BLISTER PACK in 1 CARTON (43485-104-60) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-104-01)
Marketing Start Date2016-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43485-104-60 [43485010460]

Spritam TABLET, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA207958
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-05

NDC 43485-104-01 [43485010401]

Spritam TABLET, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA207958
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-05

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM1000 mg/1

OpenFDA Data

SPL SET ID:be651c31-383f-11e4-916c-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736051
  • 1736050
  • 1736044
  • 1736045
  • 1736048
  • 1736053
  • 1736037
  • 1736047
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

    NDCBrand NameGeneric Name
    43485-102SpritamSpritam
    43485-104SpritamSpritam
    43485-101SpritamSpritam
    43485-103SpritamSpritam
    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 [Spritam]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SPRITAM
    SPRITAM
    86348604 4965262 Live/Registered
    APRECIA PHARMACEUTICALS, LLC
    2014-07-25
    SPRITAM
    SPRITAM
    85630193 4502295 Live/Registered
    APRECIA PHARMACEUTICALS, LLC
    2012-05-20

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