Fluocinonide

Product NDC
68788-8593
11-digit product format
687888593
Labeler code
68788
Product ID
68788-8593_560e561a-739e-4e19-b282-5d2920b8b3e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA073085
Marketing category
ANDA
Marketing start
2024-02-23
Substance
FLUOCINONIDE
Active strength
.5 mg/g
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/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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8593-6Fluocinonide60 g in 1 TUBECREAM603
68788-8593-6Fluocinonide1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8593-6GM - Gram68788-859390e83e2c-6b17-47e7-b86c-5c029c04457812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8593FLUOCINONIDE CREAM [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250515_f5f39a14-005a-4124-9c00-500598e28012.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNf5f39a14-005a-4124-9c00-500598e280123
103456fluocinonide 0.5 MG/ML Topical CreamSCDf5f39a14-005a-4124-9c00-500598e280123
103456fluocinonide 0.05 % Topical CreamSYf5f39a14-005a-4124-9c00-500598e280123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8593-6687888593061 TUBE in 1 CARTON (68788-8593-6) / 60 g in 1 TUBE1 tube2024-02-23NoNoHistorical