NDC 17478-035

Levetiractam

Levetiractam

Levetiractam is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Levetiracetam.

• Product ID: 17478-035_3f84f0fc-5d21-4252-b0db-ee501b19dd05
• NDC: 17478-035
• Product Type: Human Prescription Drug
• Proprietary Name: Levetiractam
• Generic Name: Levetiractam
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-05-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209934
• Labeler Name: Akorn, Inc.
• Substance Name: LEVETIRACETAM
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 17478-035-05

10 VIAL, SINGLE-DOSE in 1 CARTON (17478-035-05) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17478-035-05 [17478003505]

Levetiractam INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA209934
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-04

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	100 mg/mL

OpenFDA Data

• SPL SET ID: 32c9c07a-1ae1-4649-9512-4e16a30bc057
• Manufacturer:
  • Akorn, Inc.
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 647121

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]