FDA.reportPublic FDA data

Verkazia

Product NDC
82667-014
11-digit product format
826670014
Labeler code
82667
Product ID
82667-014_4dc90c49-5f0b-50de-e063-6394a90a301c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC; TOPICAL
Labeler
Harrow Eye, LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Verkazia
Listing expiration
2027-12-31

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
82667-014-00Verkazia5 in 1 POUCHEMULSION54
82667-014-00Verkazia5 in 1 CARTONEMULSION54
82667-014-01Verkazia24 in 1 CARTONEMULSION244
82667-014-01Verkazia5 in 1 POUCHEMULSION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-014-01EA - Each82667-014d0e62414-ad1a-4d11-b825-4938088d6bb312026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590608cycloSPORINE 0.1 % Ophthalmic SuspensionPSN48651d30-9e6e-74b0-e063-6294a90a83374
2590613Verkazia 0.1 % Ophthalmic SuspensionPSN48651d30-9e6e-74b0-e063-6294a90a83374
2590613cyclosporine 1 MG/ML Ophthalmic Suspension [Verkazia]SBD48651d30-9e6e-74b0-e063-6294a90a83374
2590608cyclosporine 1 MG/ML Ophthalmic SuspensionSCD48651d30-9e6e-74b0-e063-6294a90a83374
2590608cyclosporine 0.1 % Ophthalmic SuspensionSY48651d30-9e6e-74b0-e063-6294a90a83374
2590613Verkazia 1 MG/ML Ophthalmic SuspensionSY48651d30-9e6e-74b0-e063-6294a90a83374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82667-014-00826670014005 POUCH in 1 CARTON (82667-014-00) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE5 pouch2025-12-01YesNoHistorical
82667-014-018266700140124 POUCH in 1 CARTON (82667-014-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE24 pouch2025-12-01NoNoHistorical