NDC Code(s) : 54569-2177-0, 54569-4210-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FluocinonideFluocinonide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-2177(NDC:51672-1253)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide(UNII: 2W4A77YPAN)
(Fluocinonide - UNII:2W4A77YPAN) 		Fluocinonide0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
citric acid monohydrate(UNII: 2968PHW8QP)
glycerin(UNII: PDC6A3C0OX)
1,2,6-hexanetriol(UNII: W45XXM0XWE)
polyethylene glycol 3350(UNII: G2M7P15E5P)
polyethylene glycol 8000(UNII: Q662QK8M3B)
propylene glycol(UNII: 6DC9Q167V3)
stearyl alcohol(UNII: 2KR89I4H1Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-2177-01 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019117 06/26/1984
FluocinonideFluocinonide OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-4210(NDC:51672-1264)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide(UNII: 2W4A77YPAN)
(Fluocinonide - UNII:2W4A77YPAN) 		Fluocinonide0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
glyceryl monostearate(UNII: 230OU9XXE4)
propylene carbonate(UNII: 8D08K3S51E)
propylene glycol(UNII: 6DC9Q167V3)
petrolatum(UNII: 4T6H12BN9U)
white wax(UNII: 7G1J5DA97F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-4210-01 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075008 06/30/1999

PRINCIPAL DISPLAY PANEL

NDC 54569-2177-0

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048


2177-0.jpg

PRINCIPAL DISPLAY PANEL

NDC 54569-4210-0

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048


4210-0.jpg