NDC Code(s) : 55700-680-16
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FLUTICASONEfluticasone propionate SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-680(NDC:60432-264)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE PROPIONATE50 ug
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
PHENYLETHYL ALCOHOL(UNII: ML9LGA7468)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-680-161 in 1 BOX 09/07/2018
1120 in 1 BOTTLE, SPRAY Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078492 09/07/2018

LABELER - Lake Erie Medical DBA Quality Care Products LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 relabel(55700-680)

PRINCIPAL DISPLAY PANEL

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