NDC 43547-345

LEVETIRACETAM

Levetiracetam

LEVETIRACETAM is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Levetiracetam.

Product ID43547-345_276c7ef0-fa18-4445-9e43-9d415852f93c
NDC43547-345
Product TypeHuman Prescription Drug
Proprietary NameLEVETIRACETAM
Generic NameLevetiracetam
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA203468
Labeler NameSolco Healthcare US, LLC
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43547-345-06

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-345-06)
Marketing Start Date2014-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43547-345-50 [43547034550]

LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203468
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-01
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 43547-345-06 [43547034506]

LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-01
Inactivation Date2020-01-31
Reactivation Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:bc8644ed-3320-47b5-adf3-8b972bea8abd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 807832
  • 846378

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Medicade Reported Pricing

    43547034506 LEVETIRACETAM ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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