Fluocinonide Cream

Product NDC
68788-8105
11-digit product format
687888105
Labeler code
68788
Product ID
68788-8105_5e7e2acb-f352-479c-9334-7cc95666f3c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210554
Marketing category
ANDA
Marketing start
2021-11-03
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8105-3GM - Gram68788-810599102765-d5f2-40ae-b972-1708d017d3e012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8105FLUOCINONIDE CREAM (FLUOCINONIDE) CREAM [PREFERRED PHARMACEUTICALS INC.]5Legacy NDC20250515_33601219-6ffc-4cc3-b911-fe85a5555f90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8105-3687888105031 TUBE in 1 CARTON (68788-8105-3) > 30 g in 1 TUBE1 tube2021-11-030000-00-00NoNoCurrent