Fluocinonide

Product NDC
72603-703
11-digit product format
726030703
Labeler code
72603
Product ID
72603-703_2d8e10cf-0873-48dd-881c-a67288885012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
NorthStar RxLLC
Application
ANDA209283
Marketing category
ANDA
Marketing start
2025-07-01
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
72603-703-01Fluocinonide60 mL in 1 BOTTLESOLUTION602
72603-703-01Fluocinonide1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-703-01ML - Milliliter72603-703c713e2cc-4ab9-48c1-9dc1-4d8b295fdf0712025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-703FLUOCINONIDE SOLUTION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20250101_6ae5147c-84c8-4fc8-9bfe-5489e856e890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSN6ae5147c-84c8-4fc8-9bfe-5489e856e8902
310364fluocinonide 0.5 MG/ML Topical SolutionSCD6ae5147c-84c8-4fc8-9bfe-5489e856e8902
310364fluocinonide 0.05 % Topical SolutionSY6ae5147c-84c8-4fc8-9bfe-5489e856e8902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-703-01726030703011 BOTTLE in 1 CARTON (72603-703-01) / 60 mL in 1 BOTTLE1 bottle2025-07-01NoNoHistorical