FDA.reportPublic FDA data

Verkazia

Product NDC
65086-001
11-digit product format
650860001
Labeler code
65086
Product ID
65086-001_2becea0d-7cbe-6b23-e063-6294a90a5a67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC; TOPICAL
Labeler
Santen Incorporated
Application
NDA214965
Marketing category
NDA
Marketing start
2022-02-01
Substance
CYCLOSPORINE
Active strength
1 mg/mL
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Verkazia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui2590608, 2590613

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1be408a0-e15a-4092-b35e-4e294e65196fProduct name320240216
b3fdee3e-0c46-442f-aad5-aa71941d5621Product name120231023
78fb0708-fce5-decd-6611-5a9fbe3e3decProduct name320230327
54840517-000d-4fcb-b976-a6ddd102faa0Product name120220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633aProduct name120181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65086-001-05Verkazia1 in 1 CARTONEMULSION16
65086-001-05Verkazia5 in 1 POUCHEMULSION56
65086-001-12Verkazia24 in 1 CARTONEMULSION246
65086-001-12Verkazia5 in 1 POUCHEMULSION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65086-001-12EA - Each65086-0011bf0d33b-8058-4fde-bb8f-291cc0bbe4f312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65086-001VERKAZIA (CYCLOSPORINE) EMULSION [SANTEN INCORPORATED]6Current NDC, Legacy NDC, 4 package rows20250119_c795cd2f-89da-78e3-e053-2a95a90a9422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590608cycloSPORINE 0.1 % Ophthalmic SuspensionPSNc795cd2f-89da-78e3-e053-2a95a90a94226
2590613Verkazia 0.1 % Ophthalmic SuspensionPSNc795cd2f-89da-78e3-e053-2a95a90a94226
2590613cyclosporine 1 MG/ML Ophthalmic Suspension [Verkazia]SBDc795cd2f-89da-78e3-e053-2a95a90a94226
2590608cyclosporine 1 MG/ML Ophthalmic SuspensionSCDc795cd2f-89da-78e3-e053-2a95a90a94226
2590608cyclosporine 0.1 % Ophthalmic SuspensionSYc795cd2f-89da-78e3-e053-2a95a90a94226
2590613Verkazia 1 MG/ML Ophthalmic SuspensionSYc795cd2f-89da-78e3-e053-2a95a90a94226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65086-001-05650860001051 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE1 pouch2022-02-010000-00-00YesNoCurrent
65086-001-126508600011224 POUCH in 1 CARTON (65086-001-12) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE24 pouch2022-02-010000-00-00NoNoCurrent
65086-001-30650860001306 POUCH in 1 CARTON (65086-001-30) > 5 VIAL, SINGLE-DOSE in 1 POUCH > .3 mL in 1 VIAL, SINGLE-DOSE6 pouch2022-02-010000-00-00NoNoCurrent
65086-001-606508600016012 POUCH in 1 CARTON (65086-001-60) > 5 VIAL, SINGLE-DOSE in 1 POUCH > .3 mL in 1 VIAL, SINGLE-DOSE12 pouch2022-02-010000-00-00NoNoCurrent