FDA.reportPublic FDA data

CYCLOSPORINE

Product NDC
24979-126
11-digit product format
249790126
Labeler code
24979
Product ID
24979-126_8bf257be-d4c8-4694-b62b-f05124d378d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA209064
Marketing category
ANDA
Marketing start
2026-03-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOSPORINE
Listing expiration
2027-12-31

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
24979-126-18CYCLOSPORINE60 in 1 CARTONEMULSION602
24979-126-18CYCLOSPORINE0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.42
24979-126-19CYCLOSPORINE0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.42
24979-126-19CYCLOSPORINE30 in 1 CARTONEMULSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-126-18EA - Each24979-126c028195e-058c-4f7b-bb59-0cf50c586a1112026-05-22
24979-126-19EA - Each24979-126f0281816-ecdd-4544-9d2b-53ab77c5a8ff12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-126-182497901261860 VIAL, SINGLE-USE in 1 CARTON (24979-126-18) / .4 mL in 1 VIAL, SINGLE-USE2026-03-27NoNoCurrent
24979-126-192497901261930 VIAL, SINGLE-USE in 1 CARTON (24979-126-19) / .4 mL in 1 VIAL, SINGLE-USE2026-03-27NoNoCurrent