NDC 0591-3699

Levetiracetam

Levetiracetam

Levetiracetam is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Levetiracetam.

Product ID0591-3699_392da1d3-de2e-46f0-b88b-1859c40dbb62
NDC0591-3699
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-09-12
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA091093
Labeler NameActavis Pharma, Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength750 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN

Packaging

NDC 0591-3699-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3699-60)
Marketing Start Date2011-09-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3699-60 [00591369960]

Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091093
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-12
Marketing End Date2019-06-30

NDC 0591-3699-10 [00591369910]

Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091093
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-09-12
Marketing End Date2011-09-12

NDC 0591-3699-05 [00591369905]

Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091093
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-09-12
Marketing End Date2011-09-12

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM750 mg/1

OpenFDA Data

SPL SET ID:4dc61085-f769-4a14-bb99-570264f999f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 807832
  • 846378
  • UPC Code
  • 0305913699601
  • 0305913635609
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

    NDCBrand NameGeneric Name
    0054-0224LevetiracetamLevetiracetam
    0121-0799LevetiracetamLEVETIRACETAM
    0121-1598LevetiracetamLEVETIRACETAM
    0121-2397LevetiracetamLEVETIRACETAM
    0121-4799LevetiracetamLEVETIRACETAM
    0121-4802LEVETIRACETAMLEVETIRACETAM
    0143-9574LevetiracetamLevetiracetam
    0143-9673LevetiracetamLevetiracetam
    0228-2167LevetiracetamLevetiracetam
    0378-5613Levetiracetamlevetiracetam
    0378-5615Levetiracetamlevetiracetam
    0378-5617Levetiracetamlevetiracetam
    67850-012LevetiracetamLevetiracetam
    67850-014LevetiracetamLevetiracetam
    67850-013LevetiracetamLevetiracetam
    67850-011LevetiracetamLevetiracetam
    68001-116LevetiracetamLevetiracetam
    68001-113LevetiracetamLevetiracetam
    68001-115LevetiracetamLevetiracetam
    68001-114LevetiracetamLevetiracetam
    68001-117LevetiracetamLevetiracetam
    68001-118LevetiracetamLevetiracetam
    68071-4508LevetiracetamLevetiracetam
    68083-153LevetiracetamLevetiracetam
    68083-154LevetiracetamLevetiracetam
    68083-152LevetiracetamLevetiracetam
    68084-870LevetiracetamLevetiracetam
    68084-859LevetiracetamLevetiracetam
    68084-893LevetiracetamLevetiracetam
    68084-882LevetiracetamLevetiracetam
    68180-118LevetiracetamLevetiracetam
    68180-113LevetiracetamLevetiracetam
    68180-115LevetiracetamLevetiracetam
    68180-117LevetiracetamLevetiracetam
    68180-112LevetiracetamLevetiracetam
    68180-114LevetiracetamLevetiracetam
    68180-099levetiracetamlevetiracetam
    68258-7089LevetiracetamLevetiracetam
    68382-165levetiracetamlevetiracetam
    68382-168levetiracetamlevetiracetam
    0472-0235LevetiracetamLevetiracetam
    68788-7074LevetiracetamLevetiracetam
    68788-6798LevetiracetamLevetiracetam
    68788-6838LevetiracetamLevetiracetam
    68788-7190LevetiracetamLevetiracetam
    68788-6966LevetiracetamLevetiracetam
    69076-750LevetiracetamLevetiracetam
    69076-500LevetiracetamLevetiracetam
    70518-0197LevetiracetamLevetiracetam
    70518-0365LevetiracetamLevetiracetam

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