NDC 68083-154

Levetiracetam

Levetiracetam

Levetiracetam is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Levetiracetam.

Product ID68083-154_3e1fe76f-a307-43e5-9330-c169a11c1f38
NDC68083-154
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-07
Marketing CategoryANDA / ANDA
Application NumberANDA206880
Labeler NameGland Pharma Limited
Substance NameLEVETIRACETAM
Active Ingredient Strength15 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68083-154-10

10 BAG in 1 CARTON (68083-154-10) > 100 mL in 1 BAG (68083-154-01)
Marketing Start Date2017-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-154-01 [68083015401]

Levetiracetam INJECTION
Marketing CategoryANDA
Application NumberANDA206880
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-07

NDC 68083-154-10 [68083015410]

Levetiracetam INJECTION
Marketing CategoryANDA
Application NumberANDA206880
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-07

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM15 mg/mL

OpenFDA Data

SPL SET ID:aa883d9c-c6cd-44ab-a1de-058985e4f97f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1193360
  • 1193362
  • 1193358
    • UPC Code
  • 0368083153014

    • 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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