NDC 63323-400

Levetiracetam

Levetiracetam

Levetiracetam is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Levetiracetam.

Product ID63323-400_3c999836-3e9a-4a02-92bd-c557c1c1c0bf
NDC63323-400
Product TypeHuman Prescription Drug
Proprietary NameLevetiracetam
Generic NameLevetiracetam
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA090876
Labeler NameFresenius Kabi USA, LLC
Substance NameLEVETIRACETAM
Active Ingredient Strength100 mg/mL
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-400-05

10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2015-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-400-09 [63323040009]

Levetiracetam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090813
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-03
Marketing End Date2014-11-12

NDC 63323-400-05 [63323040005]

Levetiracetam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-13

NDC 63323-400-41 [63323040041]

Levetiracetam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-13

NDC 63323-400-44 [63323040044]

Levetiracetam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-13

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM100 mg/mL

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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