Fluocinonide

Product NDC
0115-1705
11-digit product format
001151705
Labeler code
0115
Product ID
0115-1705_bd2b28a4-dcd0-4af0-a2e9-1273aef02228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Impax Generics
Application
ANDA074204
Marketing category
ANDA
Marketing start
2016-03-21
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
0115-1705-522020-01-31C16284748780-19d75b9d0-d9ea-f424-e053-dadaa90a57ceFluocinonide Cream, USP 0.05% (Emulsified Base) For External Use Only Not for Ophthalmic Use Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1705-52Fluocinonide1 in 1 CARTONCREAM11
0115-1705-52Fluocinonide15 g in 1 TUBECREAM151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1705-52GM - Gram0115-17054e491e22-11fd-4334-a4ac-f0ebbc42702512017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1705FLUOCINONIDE (FLUOCINONIDE) CREAM [IMPAX GENERICS]1Legacy NDC, 2 package rows20170517_c229433a-a630-8f9a-8b8c-762ab7e1dd81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801283fluocinonide 0.05 % Emollient Base Topical CreamPSNc229433a-a630-8f9a-8b8c-762ab7e1dd811
1801283Emollient fluocinonide 0.5 MG/ML Topical CreamSCDc229433a-a630-8f9a-8b8c-762ab7e1dd811
1801283fluocinonide 0.05 % Emollient Base Topical CreamSYc229433a-a630-8f9a-8b8c-762ab7e1dd811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0115-1705-52001151705521 in 1 CARTONHistorical