Fluocinonide

Product NDC
68071-3918
11-digit product format
680713918
Labeler code
68071
Product ID
68071-3918_448400e8-cfba-5228-e063-6294a90aec0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide topical solution usp, 0.05%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
NuCare Pharmaceuticals, 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
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
68071-3918-6Fluocinonide1 in 1 CARTONSOLUTION11
68071-3918-6Fluocinonide60 mL in 1 BOTTLESOLUTION601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSN44840256-471b-a719-e063-6394a90a5a141
310364fluocinonide 0.5 MG/ML Topical SolutionSCD44840256-471b-a719-e063-6394a90a5a141
310364fluocinonide 0.05 % Topical SolutionSY44840256-471b-a719-e063-6394a90a5a141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3918-6680713918061 BOTTLE in 1 CARTON (68071-3918-6) / 60 mL in 1 BOTTLE1 bottle2025-11-26NoNoHistorical