CEQUA

Product NDC
47335-506
11-digit product format
473350506
Labeler code
47335
Product ID
47335-506_9db609da-42a0-42b1-87f5-020261a871ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC; TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA210913
Marketing category
NDA
Marketing start
2018-08-15
Substance
CYCLOSPORINE
Active strength
.0009 g/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
CEQUA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE.0009 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui2055021, 2055026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-506-96CEQUA10 in 1 POUCHSOLUTION/ DROPS1012
47335-506-96CEQUA6 in 1 BOXSOLUTION/ DROPS612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-506CEQUA (CYCLOSPORINE) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 2 package rows20250309_48c3d8a3-4289-4b52-9189-58b48596095c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055026Cequa 0.09 % Ophthalmic SolutionPSN48c3d8a3-4289-4b52-9189-58b48596095c12
2055021cycloSPORINE 0.09 % Ophthalmic SolutionPSN48c3d8a3-4289-4b52-9189-58b48596095c12
2055026cyclosporine 0.9 MG/ML Ophthalmic Solution [Cequa]SBD48c3d8a3-4289-4b52-9189-58b48596095c12
2055021cyclosporine 0.9 MG/ML Ophthalmic SolutionSCD48c3d8a3-4289-4b52-9189-58b48596095c12
2055026Cequa 0.09 % Ophthalmic SolutionSY48c3d8a3-4289-4b52-9189-58b48596095c12
2055026Cequa 0.9 MG/ML Ophthalmic SolutionSY48c3d8a3-4289-4b52-9189-58b48596095c12
2055021cyclosporine 0.09 % Ophthalmic SolutionSY48c3d8a3-4289-4b52-9189-58b48596095c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-506-96473350506966 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE6 pouch2018-08-150000-00-00NoNoCurrent