FDA.reportPublic FDA data

Cyclosporine

Product NDC
0480-4076
11-digit product format
004804076
Labeler code
0480
Product ID
0480-4076_0dc3c832-fe01-4913-ba52-47cca4c890b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA203880
Marketing category
ANDA
Marketing start
2025-10-28
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
0480-4076-30Cyclosporine6 in 1 CARTONEMULSION66
0480-4076-30Cyclosporine5 in 1 POUCHEMULSION56
0480-4076-60Cyclosporine5 in 1 POUCHEMULSION56
0480-4076-60Cyclosporine12 in 1 CARTONEMULSION126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-4076-30EA - Each0480-407630619515-01b0-4323-a532-00448bf76ba712025-11-13
0480-4076-60EA - Each0480-4076c8eaf837-650c-404f-a579-681ab3cedeca12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNcc64c1e3-19f5-4bf6-a08d-a9725004c97f6
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDcc64c1e3-19f5-4bf6-a08d-a9725004c97f6
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYcc64c1e3-19f5-4bf6-a08d-a9725004c97f6
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYcc64c1e3-19f5-4bf6-a08d-a9725004c97f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-4076-30004804076306 POUCH in 1 CARTON (0480-4076-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE6 pouch2025-10-28NoNoCurrent
0480-4076-600048040766012 POUCH in 1 CARTON (0480-4076-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE12 pouch2025-10-28NoNoCurrent