NDC 68180-214

CYCLOSPORINE

Cyclosporine

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

Product ID68180-214_9dc7a029-c21e-44af-831c-4600a4ed4421
NDC68180-214
Product TypeHuman Prescription Drug
Proprietary NameCYCLOSPORINE
Generic NameCyclosporine
Dosage FormEmulsion
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-05-11
Marketing CategoryNDA AUTHORIZED GENERIC /
Application NumberNDA050790
Labeler NameLupin 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 68180-214-30

30 VIAL, SINGLE-USE in 1 TRAY (68180-214-30) > .4 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2022-05-11
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.