FDA.reportPublic FDA data

Cyclosporine

Product NDC
73043-005
11-digit product format
730430005
Labeler code
73043
Product ID
73043-005_5135618a-f2f6-49bd-b0ea-636cb2adf84c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Devatis Inc.
Application
ANDA209811
Marketing category
ANDA
Marketing start
2024-07-04
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
73043-005-01Cyclosporine10 in 1 POUCHEMULSION102
73043-005-01Cyclosporine3 in 1 CARTONEMULSION32
73043-005-02Cyclosporine10 in 1 POUCHEMULSION102
73043-005-02Cyclosporine6 in 1 CARTONEMULSION62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73043-005CYCLOSPORINE EMULSION [DEVATIS INC.]2Current NDC, 4 package rows20250312_7bb2078d-17c2-4e6a-9f61-26c7ecbce945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSN7bb2078d-17c2-4e6a-9f61-26c7ecbce9452
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCD7bb2078d-17c2-4e6a-9f61-26c7ecbce9452
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSY7bb2078d-17c2-4e6a-9f61-26c7ecbce9452
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSY7bb2078d-17c2-4e6a-9f61-26c7ecbce9452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-005-01730430005013 POUCH in 1 CARTON (73043-005-01) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE3 pouch2024-07-04NoNoCurrent
73043-005-02730430005026 POUCH in 1 CARTON (73043-005-02) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE6 pouch2024-07-04NoNoCurrent