FDA.reportPublic FDA data

fluocinonide

Product NDC
0168-0134
11-digit product format
001680134
Labeler code
0168
Product ID
0168-0134_e2784b8c-ca35-4719-8fca-169ecc08b529
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA072934
Marketing category
ANDA
Marketing start
1995-02-27
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
0168-0134-60fluocinonide1 in 1 CARTONSOLUTION16
0168-0134-60fluocinonide60 mL in 1 BOTTLESOLUTION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0134-60ML - Milliliter0168-01347edf9087-e8ab-4ff5-a709-41947d33bd7b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
fluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
alcoholINACTIVE INGREDIENT3K9958V90MFLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
diisopropyl adipateINACTIVE INGREDIENTP7E6YFV72XFLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0134FLUOCINONIDE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20170417_ebca0c66-06f6-438a-a01a-634c53debc06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310364fluocinonide 0.05 % Topical SolutionPSNf20e4aa4-11f3-4f9d-9c29-43f7fb9c549d101
310364fluocinonide 0.5 MG/ML Topical SolutionSCDf20e4aa4-11f3-4f9d-9c29-43f7fb9c549d101
310364fluocinonide 0.05 % Topical SolutionSYf20e4aa4-11f3-4f9d-9c29-43f7fb9c549d101
310364fluocinonide 0.05 % Topical SolutionPSNebca0c66-06f6-438a-a01a-634c53debc066
310364fluocinonide 0.5 MG/ML Topical SolutionSCDebca0c66-06f6-438a-a01a-634c53debc066
310364fluocinonide 0.05 % Topical SolutionSYebca0c66-06f6-438a-a01a-634c53debc066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0134-60001680134601 BOTTLE in 1 CARTON (0168-0134-60) / 60 mL in 1 BOTTLE1 bottle1995-02-270000-00-00NoNoCurrent