NDC 47133-575

Elepsia XR

Levetiracetam

Elepsia XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharma Advanced Research Company Limited. The primary component is Levetiracetam.

Product ID47133-575_658ed9f5-ef08-47cf-85e9-014fed2a7087
NDC47133-575
Product TypeHuman Prescription Drug
Proprietary NameElepsia XR
Generic NameLevetiracetam
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-03-13
Marketing CategoryNDA / NDA
Application NumberNDA204417
Labeler NameSun Pharma Advanced Research Company Limited
Substance NameLEVETIRACETAM
Active Ingredient Strength1500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47133-575-13

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-575-13)
Marketing Start Date2019-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47133-575-83 [47133057583]

Elepsia XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA204417
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-17

NDC 47133-575-13 [47133057513]

Elepsia XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA204417
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-17

NDC 47133-575-88 [47133057588]

Elepsia XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA204417
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM1500 mg/1

OpenFDA Data

SPL SET ID:12e147dc-4f5b-4117-8a8e-a8c429ad0217
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1605362
  • 1605374
  • 1605368
  • 1605372
  • UPC Code
  • 0347133575839
  • 0347133574832
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

    NDCBrand NameGeneric Name
    47133-574Elepsia XRElepsia XR
    47133-575Elepsia XRElepsia 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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