Fluocinonide

Product NDC
33261-560
11-digit product format
332610560
Labeler code
33261
Product ID
33261-560_2339387c-9c52-4c25-afa0-04b44ac2c8fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA073085
Marketing category
ANDA
Marketing start
2018-04-30
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-560-012020-01-31C16284748780-19d75b9d0-0a39-f424-e053-dadaa90a57ceFluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-560-01Fluocinonide15 g in 1 TUBECREAM151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-560-01GM - Gram33261-5601ea11db4-6475-4d55-920d-b7a707c6d48e12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-560FLUOCINONIDE CREAM [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180823_749d0c98-c048-401c-b59e-2de9dc923af1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSN749d0c98-c048-401c-b59e-2de9dc923af11
103456fluocinonide 0.5 MG/ML Topical CreamSCD749d0c98-c048-401c-b59e-2de9dc923af11
103456fluocinonide 0.05 % Topical CreamSY749d0c98-c048-401c-b59e-2de9dc923af11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-560-013326105600115 g in 1 TUBE15 gHistorical