NDC 51862-458

Cyclosporine

Cyclosporine

Cyclosporine is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Cyclosporine.

Product ID51862-458_0522346f-70c4-4c7b-918b-159316e0523a
NDC51862-458
Product TypeHuman Prescription Drug
Proprietary NameCyclosporine
Generic NameCyclosporine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-07-18
Marketing CategoryANDA / ANDA
Application NumberANDA065044
Labeler NameMayne Pharma Inc.
Substance NameCYCLOSPORINE
Active Ingredient Strength25 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 51862-458-47

30 BLISTER PACK in 1 BOX (51862-458-47) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-458-01)
Marketing Start Date2016-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-458-01 [51862045801]

Cyclosporine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA065044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-18

NDC 51862-458-47 [51862045847]

Cyclosporine CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA065044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-18

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE25 mg/1

OpenFDA Data

SPL SET ID:e7165673-8ab1-4fc8-85e5-a67135af7a7f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835894
  • 241834
  • UPC Code
  • 0351862460472
  • Pharmacological Class

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

    Medicade Reported Pricing

    51862045847 CYCLOSPORINE MODIFIED 25 MG

    Pricing Unit: EA | Drug Type:

    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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