FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
45802-009
11-digit product format
458020009
Labeler code
45802
Product ID
45802-009_8512259d-c8ce-4b9c-ad3b-0d97b9a86077
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA202849
Marketing category
ANDA
Marketing start
2017-10-04
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinolone Acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191299

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
45802-009-10Fluocinolone Acetonide20 mL in 1 BOTTLEOIL208
45802-009-10Fluocinolone Acetonide1 in 1 CARTONOIL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-009-10ML - Milliliter45802-0092d7575c6-20ac-4519-ac15-60c34d43f11b12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-009FLUOCINOLONE ACETONIDE OIL [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20250410_e6af2549-50b5-4b7f-a0c0-de0f7626b6f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSNe6af2549-50b5-4b7f-a0c0-de0f7626b6f38
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCDe6af2549-50b5-4b7f-a0c0-de0f7626b6f38
1191299fluocinolone acetonide 0.01 % Auricular OilSYe6af2549-50b5-4b7f-a0c0-de0f7626b6f38
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSYe6af2549-50b5-4b7f-a0c0-de0f7626b6f38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-009-10458020009101 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE1 bottle2017-10-040000-00-00NoNoCurrent