NDC 0378-5617

Levetiracetam

Levetiracetam

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

Product ID0378-5617_081ce602-766b-450e-ab6d-cccd468f7040
NDC0378-5617
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-11-04
Marketing CategoryANDA / ANDA
Application NumberANDA076919
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength750 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-5617-05

500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5617-05)
Marketing Start Date2008-11-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5617-05 [00378561705]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076919
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-04

NDC 0378-5617-78 [00378561778]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076919
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-04

NDC 0378-5617-07 [00378561707]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076919
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-04
Marketing End Date2016-09-30

NDC 0378-5617-12 [00378561712]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076919
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-20
Marketing End Date2016-04-25

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM750 mg/1

OpenFDA Data

SPL SET ID:0a987d59-560f-4650-96ec-31aec81953b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311290
  • 387003
  • 311289
  • 311288
  • UPC Code
  • 0303785613787
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.