NDC 69102-200

ROWEEPRA XR

Levetiracetam

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

Product ID69102-200_601eaa2b-5c17-74c6-e053-2991aa0a1123
NDC69102-200
Product TypeHuman Prescription Drug
Proprietary NameROWEEPRA XR
Generic NameLevetiracetam
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA202095
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 69102-200-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (69102-200-60)
Marketing Start Date2018-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69102-200-60 [69102020060]

ROWEEPRA XR TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202095
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-30

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:eb66dee6-1d92-4b2d-ae4a-232faf129f24
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 807832
  • 1876012
  • 1876014
  • 846378
    • UPC Code
  • 0369102200603

    • Pharmacological Class

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

    Medicade Reported Pricing

    69102020060 ROWEEPRA XR 500 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    69102-201ROWEEPRA XRROWEEPRA XR
    69102-200ROWEEPRA XRROWEEPRA 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
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