NDC 61919-685

LEVETIRACETAM

Levetiracetam

LEVETIRACETAM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Levetiracetam.

Product ID61919-685_349e9bd5-46fe-2c64-e054-00144ff8d46c
NDC61919-685
Product TypeHuman Prescription Drug
Proprietary NameLEVETIRACETAM
Generic NameLevetiracetam
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA078154
Labeler NameDIRECT RX
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-685-72

120 TABLET, FILM COATED in 1 BOTTLE (61919-685-72)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-685-90 [61919068590]

LEVETIRACETAM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-05

NDC 61919-685-72 [61919068572]

LEVETIRACETAM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-685-60 [61919068560]

LEVETIRACETAM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:96bc35a8-eed6-4f0c-b149-1e4c533aa90e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311289
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.