FDA.reportPublic FDA data

Fluocinonide

Product NDC
33342-320
11-digit product format
333420320
Labeler code
33342
Product ID
33342-320_3e29d28d-6fd2-4abd-9f42-01ac5f421beb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209283
Marketing category
ANDA
Marketing start
2018-04-24
Substance
FLUOCINONIDE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinonide
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-320-84Fluocinonide20 mL in 1 BOTTLESOLUTION202
33342-320-84Fluocinonide1 in 1 CARTONSOLUTION12
33342-320-85Fluocinonide60 mL in 1 BOTTLESOLUTION602
33342-320-85Fluocinonide1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-320FLUOCINONIDE SOLUTION [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 4 package rows20240415_a439ac59-42f3-412b-b987-14fc152a974f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSNa439ac59-42f3-412b-b987-14fc152a974f2
310364fluocinonide 0.05 % Topical SolutionPSNcc994062-9f2e-8be3-e053-2995a90a3f8b2
310364fluocinonide 0.5 MG/ML Topical SolutionSCDa439ac59-42f3-412b-b987-14fc152a974f2
310364fluocinonide 0.5 MG/ML Topical SolutionSCDcc994062-9f2e-8be3-e053-2995a90a3f8b2
310364fluocinonide 0.05 % Topical SolutionSYa439ac59-42f3-412b-b987-14fc152a974f2
310364fluocinonide 0.05 % Topical SolutionSYcc994062-9f2e-8be3-e053-2995a90a3f8b2
310364fluocinonide 0.05 % Topical SolutionPSN351feec9-2089-e74a-e063-6394a90aa3991
310364fluocinonide 0.5 MG/ML Topical SolutionSCD351feec9-2089-e74a-e063-6394a90aa3991
310364fluocinonide 0.05 % Topical SolutionSY351feec9-2089-e74a-e063-6394a90aa3991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-320-84333420320841 BOTTLE in 1 CARTON (33342-320-84) / 20 mL in 1 BOTTLE1 bottle2018-04-240000-00-00NoNoCurrent
33342-320-85333420320851 BOTTLE in 1 CARTON (33342-320-85) / 60 mL in 1 BOTTLE1 bottle2018-04-240000-00-00NoNoCurrent