Fluocinolone Acetonide

Product NDC
50090-6780
11-digit product format
500906780
Labeler code
50090
Product ID
50090-6780_8c4a99cd-34c1-45e0-9936-a9f5cc04f6b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
OIL
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA090982
Marketing category
ANDA
Marketing start
2016-07-18
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
Brand name suffix
Oil
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
50090-6780-0Fluocinolone AcetonideOil118.28 mL in 1 BOTTLEOIL118.284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6780-0ML - Milliliter50090-6780bac1847f-f964-480c-95e1-c3bd7eb1192812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6780FLUOCINOLONE ACETONIDE OIL (FLUOCINOLONE ACETONIDE) OIL [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231031_0ff97af2-04d6-478e-8abe-ca5a0c675708.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191307fluocinolone acetonide 0.01 % Topical OilPSN0ff97af2-04d6-478e-8abe-ca5a0c6757084
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCD0ff97af2-04d6-478e-8abe-ca5a0c6757084
1191307fluocinolone acetonide 0.01 % Topical OilSY0ff97af2-04d6-478e-8abe-ca5a0c6757084
1191307fluocinolone acetonide 0.011 % Topical OilSY0ff97af2-04d6-478e-8abe-ca5a0c6757084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6780-050090678000118.28 mL in 1 BOTTLE (50090-6780-0) 118.28 ml2023-10-26NoNoCurrent