FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
52565-020
11-digit product format
525650020
Labeler code
52565
Product ID
52565-020_cc078a70-6715-4610-8eed-bd20ac4062a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
NDA012787
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-12-28
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-020-152022-01-28C16284748780-1d6a99b39-8346-a426-e053-dadaa90af4c2Fluocinolone Acetonide Cream USP, 0.01%, 0.025%
52565-020-602022-01-28C16284748780-1d6a99b39-8346-a426-e053-dadaa90af4c2Fluocinolone Acetonide Cream USP, 0.01%, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-020-15Fluocinolone Acetonide1 in 1 CARTONCREAM14
52565-020-15Fluocinolone Acetonide15 g in 1 TUBECREAM154
52565-020-60Fluocinolone Acetonide60 g in 1 TUBECREAM604
52565-020-60Fluocinolone Acetonide1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-020-15GM - Gram52565-020cd445cf2-41fb-4df8-ba87-cad9a6a74fcf12013-03-03
52565-020-60GM - Gram52565-0209c4506fe-9073-4545-8b9b-140c8079896a12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluocinolone AcetonideACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Fluocinolone AcetonideACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Cyclomethicone 4INACTIVE INGREDIENTCZ227117JEFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Mineral OilINACTIVE INGREDIENTT5L8T28FGPFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUYFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2
White WaxINACTIVE INGREDIENT7G1J5DA97FFLUOCINOLONE ACETONIDE CREAM [IGI LABS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-020FLUOCINOLONE ACETONIDE CREAM [TELIGENT PHARMA, INC.]4Legacy NDC, 4 package rows20181017_da65dffd-a017-46dd-8a5b-a4e4574c4abc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191302fluocinolone acetonide 0.01 % Topical CreamPSNda65dffd-a017-46dd-8a5b-a4e4574c4abc4
1191315fluocinolone acetonide 0.025 % Topical CreamPSNda65dffd-a017-46dd-8a5b-a4e4574c4abc4
1191302fluocinolone acetonide 0.1 MG/ML Topical CreamSCDda65dffd-a017-46dd-8a5b-a4e4574c4abc4
1191315fluocinolone acetonide 0.25 MG/ML Topical CreamSCDda65dffd-a017-46dd-8a5b-a4e4574c4abc4
1191302fluocinolone acetonide 0.01 % Topical CreamSYda65dffd-a017-46dd-8a5b-a4e4574c4abc4
1191315fluocinolone acetonide 0.025 % Topical CreamSYda65dffd-a017-46dd-8a5b-a4e4574c4abc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-020-15525650020151 TUBE in 1 CARTON (52565-020-15) > 15 g in 1 TUBE1 tube2014-05-150000-00-00NoNoCurrent
52565-020-60525650020601 TUBE in 1 CARTON (52565-020-60) > 60 g in 1 TUBE1 tube2014-05-150000-00-00NoNoCurrent