NDC 0121-4799

Levetiracetam

Levetiracetam

Levetiracetam is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Levetiracetam.

Product ID0121-4799_5f390f7d-cdd5-d745-e053-2991aa0a46da
NDC0121-4799
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA201157
Labeler NamePharmaceutical Associates, Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/5mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0121-4799-40

4 TRAY in 1 CASE (0121-4799-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05)
Marketing Start Date2015-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4799-15 [00121479915]

Levetiracetam SOLUTION
Marketing CategoryANDA
Application NumberANDA201157
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-04
Marketing End Date2017-10-26

NDC 0121-4799-10 [00121479910]

Levetiracetam SOLUTION
Marketing CategoryANDA
Application NumberANDA201157
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-04
Marketing End Date2017-10-26

NDC 0121-4799-05 [00121479905]

Levetiracetam SOLUTION
Marketing CategoryANDA
Application NumberANDA201157
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-04

NDC 0121-4799-50 [00121479950]

Levetiracetam SOLUTION
Marketing CategoryANDA
Application NumberANDA201157
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-28

NDC 0121-4799-40 [00121479940]

Levetiracetam SOLUTION
Marketing CategoryANDA
Application NumberANDA201157
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-04

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/5mL

OpenFDA Data

SPL SET ID:9dca1330-52ca-47a4-a134-ec55c9d5786d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403884

    • 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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