FDA.reportPublic FDA data

Fluocinonide

Product NDC
21922-001
11-digit product format
219220001
Labeler code
21922
Product ID
21922-001_85d64cb1-93f5-480d-b454-ca43810c8539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide topical solution usp, 0.05%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA209699
Marketing category
ANDA
Marketing start
2019-04-19
Substance
FLUOCINONIDE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui310364

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
21922-001-012021-11-24C16284748780-1ba0f9c33-4fd6-a910-e053-dadaa90a0b85Fluocinonide Topical Solution USP, 0.05%
21922-001-012021-11-24C16284748780-1ba0f9c33-4fd6-a910-e053-dadaa90a0b85Fluocinonide Topical Solution USP, 0.05%
21922-001-012021-11-24C16284748780-1ba0f9c33-4fd6-a910-e053-dadaa90a0b85Fluocinonide Topical Solution USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-001-01Fluocinonide1 in 1 CARTONSOLUTION17
21922-001-01Fluocinonide60 mL in 1 BOTTLESOLUTION607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-001FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED]5Current NDC, Legacy NDC, 2 package rows20220118_4b1f775e-a7ad-4151-975e-6026296b5cea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSN38a36184-22b4-4e97-83e1-fdd984ef6ccb104
310364fluocinonide 0.5 MG/ML Topical SolutionSCD38a36184-22b4-4e97-83e1-fdd984ef6ccb104
310364fluocinonide 0.05 % Topical SolutionSY38a36184-22b4-4e97-83e1-fdd984ef6ccb104
310364fluocinonide 0.05 % Topical SolutionPSN628bda7e-b670-4f71-bcc4-0290d67655a0102
310364fluocinonide 0.5 MG/ML Topical SolutionSCD628bda7e-b670-4f71-bcc4-0290d67655a0102
310364fluocinonide 0.05 % Topical SolutionSY628bda7e-b670-4f71-bcc4-0290d67655a0102
310364fluocinonide 0.05 % Topical SolutionPSN4b1f775e-a7ad-4151-975e-6026296b5cea7
310364fluocinonide 0.5 MG/ML Topical SolutionSCD4b1f775e-a7ad-4151-975e-6026296b5cea7
310364fluocinonide 0.05 % Topical SolutionSY4b1f775e-a7ad-4151-975e-6026296b5cea7
310364fluocinonide 0.05 % Topical SolutionPSN44840256-471b-a719-e063-6394a90a5a141
310364fluocinonide 0.05 % Topical SolutionPSNf560ead8-946f-3c79-e053-2995a90a9ea21
310364fluocinonide 0.5 MG/ML Topical SolutionSCD44840256-471b-a719-e063-6394a90a5a141
310364fluocinonide 0.5 MG/ML Topical SolutionSCDf560ead8-946f-3c79-e053-2995a90a9ea21
310364fluocinonide 0.05 % Topical SolutionSY44840256-471b-a719-e063-6394a90a5a141
310364fluocinonide 0.05 % Topical SolutionSYf560ead8-946f-3c79-e053-2995a90a9ea21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-001-01219220001011 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLE1 bottle2019-04-190000-00-00NoNoCurrent