NDC 65977-5037

Levetiracetam

Levetiracetam

Levetiracetam is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Hetero Drugs Ltd.,. The primary component is Levetiracetam.

Product ID65977-5037_b9acd365-1b80-4428-bd33-3a5eac814677
NDC65977-5037
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA090515
Labeler NameHetero Drugs Ltd.,
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65977-5037-0

30 TABLET, FILM COATED in 1 BOTTLE (65977-5037-0)
Marketing Start Date2010-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65977-5037-1 [65977503701]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090515
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08
Inactivation Date2019-10-29

NDC 65977-5037-0 [65977503700]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090515
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08
Inactivation Date2019-10-29

NDC 65977-5037-3 [65977503703]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090515
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08
Inactivation Date2019-10-29

NDC 65977-5037-2 [65977503702]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090515
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08
Inactivation Date2019-10-29

NDC 65977-5037-4 [65977503704]

Levetiracetam TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090515
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:b9acd365-1b80-4428-bd33-3a5eac814677
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311290
  • 387003
  • 311289
  • 311288
    • UPC Code
  • 0365977503900
  • 0365977503801

    • 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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