FDA.reportPublic FDA data

Iluvien

Product NDC
68611-190
11-digit product format
686110190
Labeler code
68611
Product ID
68611-190_78b978f0-fc11-11f0-b558-0800200c9a66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
IMPLANT
Route
INTRAVITREAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA201923
Marketing category
NDA
Marketing start
2014-10-15
Substance
FLUOCINOLONE ACETONIDE
Active strength
.19 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.19 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1552351, 1552356

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68611-190-02Iluvien1 in 1 TRAYIMPLANT120
68611-190-02Iluvien1 in 1 CARTONIMPLANT120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68611-190-02EA - Each68611-1904ac38697-b8c1-4c67-ae02-1f9b3f558a5a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINOLONE ACETONIDEACTIVE INGREDIENT0CD5FD6S2MILUVIEN (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.]8
FLUOCINOLONE ACETONIDEACTIVE MOIETY0CD5FD6S2MILUVIEN (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ILUVIEN (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RILUVIEN (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68611-190ILUVIEN (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.]18Current NDC, Legacy NDC, 2 package rows20250326_4400e471-7402-11df-93f2-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1552351fluocinolone acetonide 0.19 MG Intravitreal Drug ImplantPSN4400e471-7402-11df-93f2-0800200c9a6620
1552356ILUVIEN 0.19 MG Intravitreal Drug ImplantPSN4400e471-7402-11df-93f2-0800200c9a6620
1552356fluocinolone acetonide 0.19 MG Drug Implant [Iluvien]SBD4400e471-7402-11df-93f2-0800200c9a6620
1552351fluocinolone acetonide 0.19 MG Drug ImplantSCD4400e471-7402-11df-93f2-0800200c9a6620
1552356Iluvien 0.19 MG Drug ImplantSY4400e471-7402-11df-93f2-0800200c9a6620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68611-190-02686110190021 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR1 tray2014-10-150000-00-00NoNoCurrent