cyclosporine

Generic: cyclosporine

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler apotex corp
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

cyclosporine .5 mg/mL

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-6202
Product ID 60505-6202_58c5fb86-01c3-497b-86f7-a65055732970
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050790
Listing Expiration 2026-12-31
Marketing Start 2022-02-07

Pharmacologic Class

Established (EPC)
calcineurin inhibitor immunosuppressant [epc]
Mechanism of Action
calcineurin inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056202
Hyphenated Format 60505-6202

Supplemental Identifiers

RxCUI
2572292
UPC
0360505620227 0360505620210
UNII
83HN0GTJ6D
NUI
N0000175457 N0000175458 N0000182141 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cyclosporine (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number NDA050790 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 30 VIAL in 1 TRAY (60505-6202-1) / .4 mL in 1 VIAL
  • 60 VIAL in 1 TRAY (60505-6202-2) / .4 mL in 1 VIAL
source: ndc

Packages (2)

60505-6202-1 30 VIAL in 1 TRAY (60505-6202-1) / .4 mL in 1 VIAL 60505-6202-2 60 VIAL in 1 TRAY (60505-6202-2) / .4 mL in 1 VIAL

Ingredients (1)

cyclosporine (.5 mg/mL)

Linked Drug Pages (1)

Cyclosporine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "58c5fb86-01c3-497b-86f7-a65055732970", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "upc": ["0360505620227", "0360505620210"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292"], "spl_set_id": ["70c8a4a6-ebe2-457f-a626-400c338cec2d"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL in 1 TRAY (60505-6202-1)  / .4 mL in 1 VIAL", "package_ndc": "60505-6202-1", "marketing_start_date": "20220207"}, {"sample": false, "description": "60 VIAL in 1 TRAY (60505-6202-2)  / .4 mL in 1 VIAL", "package_ndc": "60505-6202-2", "marketing_start_date": "20220207"}], "brand_name": "Cyclosporine", "product_id": "60505-6202_58c5fb86-01c3-497b-86f7-a65055732970", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "60505-6202", "generic_name": "Cyclosporine", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".5 mg/mL"}], "application_number": "NDA050790", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220207", "listing_expiration_date": "20261231"}