vevye

Generic: cyclosporine ophthalmic solution

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vevye
Generic Name cyclosporine ophthalmic solution
Labeler harrow eye, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

cyclosporine 1 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-900
Product ID 82667-900_4bc25aeb-44ca-06b2-e063-6294a90a03c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217469
Listing Expiration 2027-12-31
Marketing Start 2023-12-01

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 82667900
Hyphenated Format 82667-900

Supplemental Identifiers

RxCUI
2639936 2639941
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 vevye (source: ndc)
Generic Name cyclosporine ophthalmic solution (source: ndc)
Application Number NDA217469 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82667-900-00 1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER 82667-900-02 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER

Ingredients (1)

cyclosporine (1 mg/mL)

Linked Drug Pages (1)

VEVYE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4bc25aeb-44ca-06b2-e063-6294a90a03c0", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["2639936", "2639941"], "spl_set_id": ["0a60fccf-7e1b-44fe-e063-6394a90aadd5"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (82667-900-00)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "82667-900-00", "marketing_start_date": "20260224"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82667-900-02)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "82667-900-02", "marketing_start_date": "20231201"}], "brand_name": "VEVYE", "product_id": "82667-900_4bc25aeb-44ca-06b2-e063-6294a90a03c0", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "82667-900", "generic_name": "cyclosporine ophthalmic solution", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VEVYE", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "1 mg/mL"}], "application_number": "NDA217469", "marketing_category": "NDA", "marketing_start_date": "20231201", "listing_expiration_date": "20271231"}