RESTASIS

Product NDC
50090-1242
11-digit product format
500901242
Labeler code
50090
Product ID
50090-1242_2af9d19d-a029-4d25-9d01-99e7caf324a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
NDA050790
Marketing category
NDA
Marketing start
2003-04-01
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1242-0RESTASIS30 in 1 TRAYEMULSION3016
50090-1242-0RESTASIS.4 mL in 1 VIAL, SINGLE-USEEMULSION.416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1242-0EA - Each50090-12423a77b3fb-f609-4604-8b61-c562064b812512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1242RESTASIS (CYCLOSPORINE) EMULSION [A-S MEDICATION SOLUTIONS]16Legacy NDC, 2 package rows20210415_ce9325ab-fca1-4dae-8e53-a46ec95d3a76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNce9325ab-fca1-4dae-8e53-a46ec95d3a7616
2572293Restasis 0.05 % in 0.4 ML Ophthalmic EmulsionPSNce9325ab-fca1-4dae-8e53-a46ec95d3a7616
25722930.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension [Restasis]SBDce9325ab-fca1-4dae-8e53-a46ec95d3a7616
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDce9325ab-fca1-4dae-8e53-a46ec95d3a7616
25722930.4 ML Restasis 0.5 MG/ML Ophthalmic SuspensionSYce9325ab-fca1-4dae-8e53-a46ec95d3a7616
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYce9325ab-fca1-4dae-8e53-a46ec95d3a7616
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYce9325ab-fca1-4dae-8e53-a46ec95d3a7616
2572293Restasis 0.05 % per 0.4 ML Ophthalmic SuspensionSYce9325ab-fca1-4dae-8e53-a46ec95d3a7616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1242-05009012420030 VIAL, SINGLE-USE in 1 TRAY (50090-1242-0) > .4 mL in 1 VIAL, SINGLE-USE2014-11-280000-00-00NoNoCurrent