FDA.reportPublic FDA data

Fluocinonide

Product NDC
52959-652
11-digit product format
529590652
Labeler code
52959
Product ID
52959-652_baed54e9-abeb-436b-bb53-114bd11e8001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
GEL
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA072537
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-652-602019-11-13C16284748780-197449f38-d382-f6ea-e053-dbdaa90aa703FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE GEL USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 0265 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-652-60Fluocinonide60 g in 1 TUBEGEL602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-652-60GM - Gram52959-6529d197025-c38d-4b03-86f1-c1bdde33663612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINONIDEACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE GEL [H.J. HARKINS COMPANY, INC.]2
FLUOCINONIDEACTIVE MOIETY2W4A77YPANFLUOCINONIDE GEL [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-652FLUOCINONIDE GEL [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20111223_4d42b775-f487-4fb2-83b7-c34baa1cab0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310362fluocinonide 0.05 % Topical GelPSN4d42b775-f487-4fb2-83b7-c34baa1cab0b2
310362fluocinonide 0.0005 MG/MG Topical GelSCD4d42b775-f487-4fb2-83b7-c34baa1cab0b2
310362fluocinonide 0.05 % Topical GelSY4d42b775-f487-4fb2-83b7-c34baa1cab0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-652-605295906526060 g in 1 TUBE60 gHistorical