FDA.reportPublic FDA data

Cyclosporine

Product NDC
60505-6202
11-digit product format
605056202
Labeler code
60505
Product ID
60505-6202_58c5fb86-01c3-497b-86f7-a65055732970
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Apotex Corp
Application
NDA050790
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-02-07
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
Cyclosporine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui2572292

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
60505-6202-1Cyclosporine30 in 1 TRAYEMULSION304
60505-6202-1Cyclosporine0.4 mL in 1 VIALEMULSION0.44
60505-6202-2Cyclosporine60 in 1 TRAYEMULSION604
60505-6202-2Cyclosporine0.4 mL in 1 VIALEMULSION0.44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6202-1EA - Each60505-6202ad929868-5ab4-45d0-80a8-67f27ef366f212022-03-09
60505-6202-2EA - Each60505-6202f0eef87e-934c-4160-a789-ca7e49f0093812022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6202CYCLOSPORINE EMULSION [APOTEX CORP]4Current NDC, Legacy NDC, 4 package rows20241228_70c8a4a6-ebe2-457f-a626-400c338cec2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSN70c8a4a6-ebe2-457f-a626-400c338cec2d4
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCD70c8a4a6-ebe2-457f-a626-400c338cec2d4
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSY70c8a4a6-ebe2-457f-a626-400c338cec2d4
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSY70c8a4a6-ebe2-457f-a626-400c338cec2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6202-16050562020130 VIAL in 1 TRAY (60505-6202-1) / .4 mL in 1 VIAL30 vial2022-02-070000-00-00NoNoCurrent
60505-6202-26050562020260 VIAL in 1 TRAY (60505-6202-2) / .4 mL in 1 VIAL60 vial2022-02-070000-00-00NoNoCurrent