NDC 15955-327

LEVETIRACETAM

Levetiracetam

LEVETIRACETAM is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Orit Laboratories Llc. The primary component is Levetiracetam.

Product ID15955-327_774a39b1-452c-4346-a77e-278f3b0b0db4
NDC15955-327
Product TypeHuman Prescription Drug
Proprietary NameLEVETIRACETAM
Generic NameLevetiracetam
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2012-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA203067
Labeler NameOrit Laboratories LLC
Substance NameLEVETIRACETAM
Active Ingredient Strength100 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 15955-327-16

473 mL in 1 BOTTLE, PLASTIC (15955-327-16)
Marketing Start Date2012-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15955-327-16 [15955032716]

LEVETIRACETAM SOLUTION
Marketing CategoryANDA
Application NumberANDA203067
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM100 mg/mL

OpenFDA Data

SPL SET ID:50af33cb-7abd-4e9f-ae5b-953eb2b836d9
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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