FDA.reportPublic FDA data

Fluocinonide

Product NDC
50090-1784
11-digit product format
500901784
Labeler code
50090
Product ID
50090-1784_d04a497f-2bc7-414e-a490-c6938647f1c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA072488
Marketing category
ANDA
Marketing start
1990-09-30
Substance
FLUOCINONIDE
Active strength
.5 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
FLUOCINONIDE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W4A77YPAN
Rxcui103456

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1784-02023-02-06C16284748780-1f386c649-b78f-0266-e053-dadaa90a7c1aFLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only
50090-1784-02023-01-30C16284748780-1f386c649-b78f-0266-e053-dadaa90a7c1aFLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1784-0Fluocinonide1 in 1 CARTONCREAM112
50090-1784-0Fluocinonide30 g in 1 TUBECREAM3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1784-0GM - Gram50090-1784da9496f8-d8e7-4b0e-890d-f17adb3841be12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1784FLUOCINONIDE CREAM [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20241107_ce75f0e1-c536-40ad-b77f-2e3ec29caeb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNce75f0e1-c536-40ad-b77f-2e3ec29caeb712
103456fluocinonide 0.5 MG/ML Topical CreamSCDce75f0e1-c536-40ad-b77f-2e3ec29caeb712
103456fluocinonide 0.05 % Topical CreamSYce75f0e1-c536-40ad-b77f-2e3ec29caeb712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1784-0500901784001 TUBE in 1 CARTON (50090-1784-0) / 30 g in 1 TUBE1 tube2015-04-170000-00-00NoNoCurrent