Fluocinonide

Product NDC
53002-9202
11-digit product format
530029202
Labeler code
53002
Product ID
53002-9202_28c867b0-31db-487d-8df1-cf5dad9c044a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA071500
Marketing category
ANDA
Marketing start
2016-10-27
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-9202-12025-01-30C16284748780-12cef2736-6142-d83d-e063-dadaa90ab31fFluocinonide Cream USP, 0.05%
53002-9202-22025-01-30C16284748780-12cef2736-6142-d83d-e063-dadaa90ab31fFluocinonide Cream USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9202-1Fluocinonide15 g in 1 TUBECREAM151
53002-9202-2Fluocinonide15 g in 1 TUBECREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9202FLUOCINONIDE CREAM [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_d823803c-a125-4695-a04b-6c14b6a66ab6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNd823803c-a125-4695-a04b-6c14b6a66ab61
103456fluocinonide 0.5 MG/ML Topical CreamSCDd823803c-a125-4695-a04b-6c14b6a66ab61
103456fluocinonide 0.05 % Topical CreamSYd823803c-a125-4695-a04b-6c14b6a66ab61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9202-15300292020115 g in 1 TUBE (53002-9202-1) 15 g2021-01-010000-00-00NoNoCurrent
53002-9202-25300292020215 g in 1 TUBE (53002-9202-2) 15 g2021-01-010000-00-00NoNoCurrent