Fluocinonide

Product NDC
63629-9583
11-digit product format
636299583
Labeler code
63629
Product ID
63629-9583_d174142a-4f0d-4f7b-ab7d-c821590a2361
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide topical solution usp, 0.05%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9583-1Fluocinonide60 mL in 1 BOTTLESOLUTION60104
63629-9583-1Fluocinonide1 in 1 CARTONSOLUTION1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9583FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240816_38a36184-22b4-4e97-83e1-fdd984ef6ccb.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9583-1636299583011 BOTTLE in 1 CARTON (63629-9583-1) / 60 mL in 1 BOTTLE1 bottle2022-12-120000-00-00NoNoCurrent