NDC 0172-7313

Cyclosporine

Cyclosporine

Cyclosporine is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Cyclosporine.

Product ID0172-7313_413d560c-b3e5-4187-9df9-7f843f95b063
NDC0172-7313
Product TypeHuman Prescription Drug
Proprietary NameCyclosporine
Generic NameCyclosporine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2005-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA065078
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameCYCLOSPORINE
Active Ingredient Strength100 mg/mL
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0172-7313-20

1 BOTTLE in 1 PACKAGE (0172-7313-20) > 50 mL in 1 BOTTLE
Marketing Start Date2005-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0172-7313-20 [00172731320]

Cyclosporine SOLUTION
Marketing CategoryANDA
Application NumberANDA065078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-03-29

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE100 mg/mL

OpenFDA Data

SPL SET ID:f3dc2a50-1084-4190-a6f3-37034a04db86
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835886
  • Pharmacological Class

    • Calcineurin Inhibitor Immunosuppressant [EPC]
    • Calcineurin Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    68084-921CyclosporineCyclosporine
    68084-879CyclosporineCyclosporine
    0574-0866CyclosporineCyclosporine
    0172-7313CyclosporineCyclosporine
    0185-0932CyclosporineCyclosporine
    0185-0933CyclosporineCyclosporine
    51862-460CyclosporineCyclosporine
    51862-458CyclosporineCyclosporine
    60505-0134CyclosporineCyclosporine
    60505-0133CyclosporineCyclosporine
    0517-0866CyclosporineCyclosporine
    0074-3108GengrafCyclosporine
    0074-3109GengrafCyclosporine
    0074-7269GengrafCyclosporine
    0078-0246Neoralcyclosporine
    0078-0248Neoralcyclosporine
    0023-9163RESTASIScyclosporine
    0023-5301Restasis MultiDosecyclosporine
    0078-0109Sandimmunecyclosporine
    0078-0110Sandimmunecyclosporine
    0078-0240Sandimmunecyclosporine
    0078-0241Sandimmunecyclosporine

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