verkazia

Generic: cyclosporine

Labeler: santen incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name verkazia
Generic Name cyclosporine
Labeler santen incorporated
Dosage Form EMULSION
Routes
OPHTHALMIC TOPICAL
Active Ingredients

cyclosporine 1 mg/mL

Manufacturer
Santen Incorporated

Identifiers & Regulatory

Product NDC 65086-001
Product ID 65086-001_2becea0d-7cbe-6b23-e063-6294a90a5a67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214965
Listing Expiration 2026-12-31
Marketing Start 2022-02-01

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 65086001
Hyphenated Format 65086-001

Supplemental Identifiers

RxCUI
2590608 2590613
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 verkazia (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number NDA214965 (source: ndc)
Routes
OPHTHALMIC TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
  • 24 POUCH in 1 CARTON (65086-001-12) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

65086-001-05 1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE 65086-001-12 24 POUCH in 1 CARTON (65086-001-12) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cyclosporine (1 mg/mL)

Linked Drug Pages (1)

Verkazia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC", "TOPICAL"], "spl_id": "2becea0d-7cbe-6b23-e063-6294a90a5a67", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["2590608", "2590613"], "spl_set_id": ["c795cd2f-89da-78e3-e053-2a95a90a9422"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Santen Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 POUCH in 1 CARTON (65086-001-05)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65086-001-05", "marketing_start_date": "20220201"}, {"sample": false, "description": "24 POUCH in 1 CARTON (65086-001-12)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65086-001-12", "marketing_start_date": "20220201"}], "brand_name": "Verkazia", "product_id": "65086-001_2becea0d-7cbe-6b23-e063-6294a90a5a67", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "65086-001", "generic_name": "cyclosporine", "labeler_name": "Santen Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Verkazia", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "1 mg/mL"}], "application_number": "NDA214965", "marketing_category": "NDA", "marketing_start_date": "20220201", "listing_expiration_date": "20261231"}