FDA.reportPublic FDA data

Fluocinolone Acetonide Topical

Product NDC
0591-2990
11-digit product format
005912990
Labeler code
0591
Product ID
0591-2990_8c1b96a1-47e6-4fac-9bda-0b299ac25800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208386
Marketing category
ANDA
Marketing start
2016-12-07
Substance
FLUOCINOLONE ACETONIDE
Active strength
.1 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 Topical
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191310

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
0591-2990-60Fluocinolone Acetonide Topical1 in 1 CARTONSOLUTION112
0591-2990-60Fluocinolone Acetonide Topical60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2990-60ML - Milliliter0591-299039c43dee-ca54-4f2d-8a1d-71542088e9f412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2990FLUOCINOLONE ACETONIDE TOPICAL SOLUTION [ACTAVIS PHARMA, INC.]12Current NDC, Legacy NDC, 2 package rows20181207_98dfd7a4-2208-4637-acf5-080a5813a433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSN98dfd7a4-2208-4637-acf5-080a5813a43312
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCD98dfd7a4-2208-4637-acf5-080a5813a43312
1191310fluocinolone acetonide 0.01 % Topical SolutionSY98dfd7a4-2208-4637-acf5-080a5813a43312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2990-60005912990601 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR2016-12-070000-00-00NoNoCurrent