FDA.reportPublic FDA data

RESTASIS

Product NDC
0023-9163
11-digit product format
000239163
Labeler code
0023
Product ID
0023-9163_3b350ae7-28e6-4dbd-824c-d0fe46b81e5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Allergan, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-9163-12RESTASIS0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.419
0023-9163-12RESTASIS5 in 1 CARTONEMULSION519
0023-9163-30RESTASIS0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.419
0023-9163-30RESTASIS30 in 1 TRAYEMULSION3019
0023-9163-60RESTASIS60 in 1 TRAYEMULSION6019
0023-9163-60RESTASIS0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9163-30EA - Each0023-9163499f317b-fbe1-417b-9a78-51eb2a931c5212012-07-24
0023-9163-60EA - Each0023-9163ba8da38d-8626-4f4d-b00e-0c18f8222f3a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyclosporineACTIVE INGREDIENT83HN0GTJ6DRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
cyclosporineACTIVE MOIETY83HN0GTJ6DRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
carbomer copolymer type AINACTIVE INGREDIENT71DD5V995LRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
castor oilINACTIVE INGREDIENTD5340Y2I9GRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
glycerinINACTIVE INGREDIENTPDC6A3C0OXRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
sodium hydroxideINACTIVE INGREDIENT55X04QC32IRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
waterINACTIVE INGREDIENT059QF0KO0RRESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]8
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RRESTASIS (CYCLOSPORINE) EMULSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9163RESTASIS (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]19Current NDC, Legacy NDC, 6 package rows20241228_8e24af2b-bc1c-4849-94f2-6df950cdca89.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
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSN8e24af2b-bc1c-4849-94f2-6df950cdca8919
2572293Restasis 0.05 % in 0.4 ML Ophthalmic EmulsionPSN8e24af2b-bc1c-4849-94f2-6df950cdca8919
25722930.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension [Restasis]SBD8e24af2b-bc1c-4849-94f2-6df950cdca8919
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCD8e24af2b-bc1c-4849-94f2-6df950cdca8919
25722930.4 ML Restasis 0.5 MG/ML Ophthalmic SuspensionSY8e24af2b-bc1c-4849-94f2-6df950cdca8919
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSY8e24af2b-bc1c-4849-94f2-6df950cdca8919
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSY8e24af2b-bc1c-4849-94f2-6df950cdca8919
2572293Restasis 0.05 % per 0.4 ML Ophthalmic SuspensionSY8e24af2b-bc1c-4849-94f2-6df950cdca8919
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
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSN8227ca35-77c1-4a08-87a3-7dcefef39bc51
2572293Restasis 0.05 % in 0.4 ML Ophthalmic EmulsionPSN8227ca35-77c1-4a08-87a3-7dcefef39bc51
25722930.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension [Restasis]SBD8227ca35-77c1-4a08-87a3-7dcefef39bc51
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCD8227ca35-77c1-4a08-87a3-7dcefef39bc51
25722930.4 ML Restasis 0.5 MG/ML Ophthalmic SuspensionSY8227ca35-77c1-4a08-87a3-7dcefef39bc51
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSY8227ca35-77c1-4a08-87a3-7dcefef39bc51
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSY8227ca35-77c1-4a08-87a3-7dcefef39bc51
2572293Restasis 0.05 % per 0.4 ML Ophthalmic SuspensionSY8227ca35-77c1-4a08-87a3-7dcefef39bc51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-9163-12000239163125 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE2003-04-010000-00-00YesNoCurrent
0023-9163-300002391633030 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USE2003-04-010000-00-00NoNoCurrent
0023-9163-600002391636060 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60) / .4 mL in 1 VIAL, SINGLE-USE2003-04-010000-00-00NoNoCurrent