NDC 0517-1045

Levocarnitine

Levocarnitine

Levocarnitine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Levocarnitine.

Product ID0517-1045_0ceed9a5-ea90-4ca3-960a-c333fab3e5e2
NDC0517-1045
Product TypeHuman Prescription Drug
Proprietary NameLevocarnitine
Generic NameLevocarnitine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2001-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA075861
Labeler NameAmerican Regent, Inc.
Substance NameLEVOCARNITINE
Active Ingredient Strength200 mg/mL
Pharm ClassesCarnitine [CS],Carnitine Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0517-1045-25

25 VIAL, SINGLE-DOSE in 1 TRAY (0517-1045-25) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2001-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-1045-25 [00517104525]

Levocarnitine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075861
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-10-08

Drug Details

Active Ingredients

IngredientStrength
LEVOCARNITINE200 mg/mL

OpenFDA Data

SPL SET ID:cc4da2c3-f939-444d-9b5b-a57b6051c190
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1791371
  • UPC Code
  • 0305171045257
  • Pharmacological Class

    • Carnitine [CS]
    • Carnitine Analog [EPC]

    NDC Crossover Matching brand name "Levocarnitine" or generic name "Levocarnitine"

    NDCBrand NameGeneric Name
    0517-1045LevocarnitineLevocarnitine
    50383-171LevocarnitineLevocarnitine
    50383-172LevocarnitineLevocarnitine
    52817-830LevocarnitineLevocarnitine
    64980-503LevocarnitineLevocarnitine
    70954-139LevocarnitineLevocarnitine Oral Solution
    70954-140LevocarnitineLevocarnitine Oral Solution (Suguar Free) 1 g/10 mL
    70954-492LevocarnitineLevocarnitine
    54482-144CARNITORlevocarnitine
    54482-145Carnitorlevocarnitine
    54482-147Carnitorlevocarnitine
    54482-148Carnitor SFlevocarnitine

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