FDA.reportPublic FDA data

RESTASIS

Product NDC
50090-4476
11-digit product format
500904476
Labeler code
50090
Product ID
50090-4476_0a22357f-0136-44d5-ab37-0a7d15287b30
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
Substance
CYCLOSPORINE
Active strength
.5 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
RESTASIS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui2572292, 2572293

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4476-02024-06-14C16284748780-1f386c649-cd71-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RESTASIS ® 0.05% safely and effectively. See full prescribing information for RESTASIS ® . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983
50090-4476-02023-01-30C16284748780-1f386c649-cd71-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RESTASIS ® 0.05% safely and effectively. See full prescribing information for RESTASIS ® . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4476-0RESTASIS.4 mL in 1 VIAL, SINGLE-USEEMULSION.421
50090-4476-0RESTASIS30 in 1 TRAYEMULSION3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4476-0EA - Each50090-4476c2a504b7-eac7-4c07-aba5-ed897ab2b63d12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4476RESTASIS (CYCLOSPORINE) EMULSION [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 2 package rows20240615_ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
2572293Restasis 0.05 % in 0.4 ML Ophthalmic EmulsionPSNee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
25722930.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension [Restasis]SBDee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
25722930.4 ML Restasis 0.5 MG/ML Ophthalmic SuspensionSYee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321
2572293Restasis 0.05 % per 0.4 ML Ophthalmic SuspensionSYee57c1c0-2fcd-4628-8e33-4e0a9dadcb0321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4476-05009044760030 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0) / .4 mL in 1 VIAL, SINGLE-USE2019-08-260000-00-00NoNoCurrent