NDC 0517-0866

Cyclosporine

Cyclosporine

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

Product ID0517-0866_63d5af89-15b2-4bf2-ad00-b35732eef6dc
NDC0517-0866
Product TypeHuman Prescription Drug
Proprietary NameCyclosporine
Generic NameCyclosporine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2003-10-07
Marketing End Date2021-04-30
Marketing CategoryUNAPPROVED DRUG FOR USE IN DRUG SHORTAGE / UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Labeler NameAmerican Regent, Inc.
Substance NameCYCLOSPORINE
Active Ingredient Strength50 mg/mL
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0517-0866-10

10 AMPULE in 1 CARTON (0517-0866-10) > 5 mL in 1 AMPULE
Marketing Start Date2003-10-07
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0866-10 [00517086610]

Cyclosporine INJECTION, SOLUTION
Marketing CategoryUNAPPROVED DRUG FOR USE IN DRUG SHOR
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-10-07
Marketing End Date2021-04-30

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE50 mg/mL

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]

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

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