Fluocinonide

Product NDC
63187-033
11-digit product format
631870033
Labeler code
63187
Product ID
63187-033_ae695028-14a8-458d-a282-77089439a0ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
NDA019117
Marketing category
NDA
Marketing start
1984-06-26
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM [PROFICIENT RX LP]1
FluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM [PROFICIENT RX LP]1
1,2,6-hexanetriolINACTIVE INGREDIENTW45XXM0XWEFLUOCINONIDE CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM [PROFICIENT RX LP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXFLUOCINONIDE CREAM [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PFLUOCINONIDE CREAM [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUOCINONIDE CREAM [PROFICIENT RX LP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM [PROFICIENT RX LP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YFLUOCINONIDE CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-033FLUOCINONIDE CREAM [PROFICIENT RX LP]3Legacy NDC20210127_f81eff3b-8386-45a6-9d00-a58634e31ffa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-033-15631870033151 TUBE in 1 CARTON (63187-033-15) > 15 g in 1 TUBE1 tube2014-06-240000-00-00NoNoCurrent