FDA.reportPublic FDA data

Fluocinonide

Product NDC
72162-2490
11-digit product format
721622490
Labeler code
72162
Product ID
72162-2490_351feed6-583e-3ce0-e063-6294a90a4074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA209283
Marketing category
ANDA
Marketing start
2025-05-14
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
72162-2490-2Fluocinonide20 mL in 1 BOTTLESOLUTION201
72162-2490-2Fluocinonide1 in 1 CARTONSOLUTION11
72162-2490-6Fluocinonide1 in 1 CARTONSOLUTION11
72162-2490-6Fluocinonide60 mL in 1 BOTTLESOLUTION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2490-2ML - Milliliter72162-2490af12b046-6079-4d0f-92b9-9f2b3a5b5b3c12025-06-13
72162-2490-6ML - Milliliter72162-2490d97746db-7c29-4bcc-8f99-0bc797e192f912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2490FLUOCINONIDE SOLUTION [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20250516_351feec9-2089-e74a-e063-6394a90aa399.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
72162-2490-2721622490021 BOTTLE in 1 CARTON (72162-2490-2) / 20 mL in 1 BOTTLE1 bottle2025-05-14NoNoCurrent
72162-2490-6721622490061 BOTTLE in 1 CARTON (72162-2490-6) / 60 mL in 1 BOTTLE1 bottle2025-05-14NoNoCurrent