NDC 59746-591

levetiracetam

Levetiracetam Injection

levetiracetam is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Jubilant Cadista Pharmaceuticals Inc.. The primary component is Levetiracetam.

Product ID59746-591_2c48c7ef-8655-4ca4-9f85-e8a5d5e33c98
NDC59746-591
Product TypeHuman Prescription Drug
Proprietary Namelevetiracetam
Generic NameLevetiracetam Injection
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-06-02
Marketing CategoryANDA / ANDA
Application NumberANDA206838
Labeler NameJubilant Cadista Pharmaceuticals Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength100 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59746-591-10

10 VIAL in 1 CARTON (59746-591-10) > 5 mL in 1 VIAL (59746-591-01)
Marketing Start Date2016-06-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59746-591-23 [59746059123]

levetiracetam INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA206838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-02

NDC 59746-591-01 [59746059101]

levetiracetam INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA206838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-02

NDC 59746-591-10 [59746059110]

levetiracetam INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA206838
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-02

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM100 mg/mL

OpenFDA Data

SPL SET ID:0d7d109f-15fc-4d95-ef6a-0e82aa98b30c
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 Injection"

    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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