NDC 0378-8760

Cyclosporine

Cyclosporine

Cyclosporine is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Cyclosporine.

Product ID0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13
NDC0378-8760
Product TypeHuman Prescription Drug
Proprietary NameCyclosporine
Generic NameCyclosporine
Dosage FormEmulsion
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-02-03
Marketing CategoryANDA /
Application NumberANDA205894
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCYCLOSPORINE
Active Ingredient Strength1 mg/mL
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-8760-58

6 POUCH in 1 CARTON (0378-8760-58) > 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) > .4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2022-02-03
NDC Exclude FlagN
Sample Package?N

Drug Details

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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