NDC 69102-104

ROWEEPRA

Levetiracetam

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

Product ID69102-104_e8c79c4a-d4e1-0a76-467f-e5c6283750b1
NDC69102-104
Product TypeHuman Prescription Drug
Proprietary NameROWEEPRA
Generic NameLevetiracetam
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-30
Marketing CategoryANDA / ANDA
Application NumberANDA090906
Labeler NameOWP Pharmaceuticals, 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 69102-104-01

120 TABLET, FILM COATED in 1 BOTTLE (69102-104-01)
Marketing Start Date2017-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69102-104-01 [69102010401]

ROWEEPRA TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090906
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-31

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:73c018ed-1019-4b0f-9c70-db3f299cee39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 387003
  • 311290
  • 1875866
  • 311289
  • 1875870
  • 1731020
  • UPC Code
  • 0369102104017
  • 0369102102013
  • 0369102103010
  • Pharmacological Class

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

    Medicade Reported Pricing

    69102010401 ROWEEPRA 500 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    69102-102ROWEEPRAROWEEPRA
    69102-104ROWEEPRAROWEEPRA
    69102-103ROWEEPRAROWEEPRA
    69102-101ROWEEPRAROWEEPRA
    69102-108RoweepraRoweepra
    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 [ROWEEPRA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROWEEPRA
    ROWEEPRA
    86634147 5209905 Live/Registered
    OWP Pharmaceuticals, Inc.
    2015-05-19

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