FDA.reportPublic FDA data

FLUOCINONIDE

Product NDC
72578-087
11-digit product format
725780087
Labeler code
72578
Product ID
72578-087_289f3db8-a73f-4141-8c35-5b3c53b9a16c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOCINONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA208989
Marketing category
ANDA
Marketing start
2020-04-30
Substance
FLUOCINONIDE
Active strength
1 mg/g
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
FLUOCINONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui485647

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-087-02FLUOCINONIDE60 g in 1 TUBECREAM602
72578-087-06FLUOCINONIDE30 g in 1 TUBECREAM302
72578-087-07FLUOCINONIDE120 g in 1 TUBECREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-087FLUOCINONIDE CREAM [VIONA PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 3 package rows20221122_248675bd-c797-46ab-adf9-f37352c33059.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSN34b5a550-4152-4f77-bc07-e4f023fca568102
485647fluocinonide 0.1 % Topical CreamPSN7055d0d3-b148-4ab3-b423-9fc417204b0a102
485647fluocinonide 0.1 % Topical CreamPSN50d06efd-9caa-4254-bf1f-eb430c5178b0102
485647fluocinonide 1 MG/ML Topical CreamSCD7055d0d3-b148-4ab3-b423-9fc417204b0a102
485647fluocinonide 1 MG/ML Topical CreamSCD34b5a550-4152-4f77-bc07-e4f023fca568102
485647fluocinonide 1 MG/ML Topical CreamSCD50d06efd-9caa-4254-bf1f-eb430c5178b0102
485647fluocinonide 0.1 % Topical CreamSY7055d0d3-b148-4ab3-b423-9fc417204b0a102
485647fluocinonide 0.1 % Topical CreamSY34b5a550-4152-4f77-bc07-e4f023fca568102
485647fluocinonide 0.1 % Topical CreamSY50d06efd-9caa-4254-bf1f-eb430c5178b0102
485647fluocinonide 1 MG per 1 GM Topical CreamSY7055d0d3-b148-4ab3-b423-9fc417204b0a102
485647fluocinonide 1 MG per 1 GM Topical CreamSY34b5a550-4152-4f77-bc07-e4f023fca568102
485647fluocinonide 1 MG per 1 GM Topical CreamSY50d06efd-9caa-4254-bf1f-eb430c5178b0102
485647fluocinonide 0.1 % Topical CreamPSN3e549888-f5f9-41da-b30d-a499da852282100
485647fluocinonide 1 MG/ML Topical CreamSCD3e549888-f5f9-41da-b30d-a499da852282100
485647fluocinonide 0.1 % Topical CreamSY3e549888-f5f9-41da-b30d-a499da852282100
485647fluocinonide 1 MG per 1 GM Topical CreamSY3e549888-f5f9-41da-b30d-a499da852282100
485647fluocinonide 0.1 % Topical CreamPSN248675bd-c797-46ab-adf9-f37352c330592
485647fluocinonide 1 MG/ML Topical CreamSCD248675bd-c797-46ab-adf9-f37352c330592
485647fluocinonide 0.1 % Topical CreamSY248675bd-c797-46ab-adf9-f37352c330592
485647fluocinonide 1 MG per 1 GM Topical CreamSY248675bd-c797-46ab-adf9-f37352c330592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-087-027257800870260 g in 1 TUBE (72578-087-02) 60 g2020-04-300000-00-00NoNoCurrent
72578-087-067257800870630 g in 1 TUBE (72578-087-06) 30 g2020-04-300000-00-00NoNoCurrent
72578-087-0772578008707120 g in 1 TUBE (72578-087-07) 120 g2020-04-300000-00-00NoNoCurrent