FDA.reportPublic FDA data

Cyclosporine

Product NDC
10702-808
11-digit product format
107020808
Labeler code
10702
Product ID
10702-808_795f036f-ee97-42b7-bd36-fff9220ce428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
KVK-TECH, INC.
Application
NDA050790
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-02-10
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
10702-808-03Cyclosporine0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.45
10702-808-03Cyclosporine30 in 1 TRAYEMULSION305
10702-808-06Cyclosporine60 in 1 TRAYEMULSION605
10702-808-06Cyclosporine0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-808CYCLOSPORINE EMULSION [KVK-TECH, INC.]5Current NDC, Legacy NDC, 4 package rows20241228_a7040dc6-063b-40ee-8f2a-153e87b08430.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNa7040dc6-063b-40ee-8f2a-153e87b084305
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDa7040dc6-063b-40ee-8f2a-153e87b084305
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYa7040dc6-063b-40ee-8f2a-153e87b084305
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYa7040dc6-063b-40ee-8f2a-153e87b084305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-808-031070208080330 VIAL, SINGLE-USE in 1 TRAY (10702-808-03) / .4 mL in 1 VIAL, SINGLE-USE2022-02-100000-00-00NoNoCurrent
10702-808-061070208080660 VIAL, SINGLE-USE in 1 TRAY (10702-808-06) / .4 mL in 1 VIAL, SINGLE-USE2022-02-100000-00-00NoNoCurrent