FLUOCINOLONE ACETONIDE

Product NDC
72162-2320
11-digit product format
721622320
Labeler code
72162
Product ID
72162-2320_e42c0c6a-991e-4e2e-96af-8e494d43cce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Bryant Ranch Prepack
Application
ANDA212762
Marketing category
ANDA
Marketing start
2021-04-02
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
72162-2320-2FLUOCINOLONE ACETONIDE1 in 1 CARTONOIL1102
72162-2320-2FLUOCINOLONE ACETONIDE20 mL in 1 BOTTLEOIL20102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2320-2ML - Milliliter72162-23204e46d66c-b0f4-4779-bb36-cc0771b8a41d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2320FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20241109_7954bdec-1b75-41d1-8c19-500eceaf6655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.01 % Auricular OilSY7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSY7954bdec-1b75-41d1-8c19-500eceaf6655102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2320-2721622320021 BOTTLE in 1 CARTON (72162-2320-2) / 20 mL in 1 BOTTLE1 bottle2024-05-20NoNoHistorical