NDC 14335-050

Levetiracetam

Levetiracetam

Levetiracetam is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hainan Poly Pharm. Co., Ltd.. The primary component is Levetiracetam.

Product ID14335-050_7bcb0387-53da-281d-e053-2991aa0ac67b
NDC14335-050
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA209781
Labeler NameHainan Poly Pharm. Co., Ltd.
Substance NameLEVETIRACETAM
Active Ingredient Strength100 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 14335-050-25

25 VIAL, SINGLE-USE in 1 CARTON (14335-050-25) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2018-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14335-050-10 [14335005010]

Levetiracetam INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-30
Inactivation Date2020-01-31

NDC 14335-050-01 [14335005001]

Levetiracetam INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-28
Marketing End Date2018-11-29

NDC 14335-050-25 [14335005025]

Levetiracetam INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM100 mg/mL

OpenFDA Data

SPL SET ID:80019d2e-4aec-41f0-ab91-03ca9ffd798d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 647121

    • 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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