FLUTICASONE (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

004
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620-01
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611-01
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FLUTICASONE
fluticasone spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-611(NDC:0054-3270)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 50 ug
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
DEXTROSE, UNSPECIFIED FORM
POLYSORBATE 80
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-611-01 120 SPRAY, METERED in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076504 02/22/2019
FLUTICASONE
fluticasone spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-620(NDC:50383-700)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 50 ug in 0.1 g
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
DEXTROSE, UNSPECIFIED FORM
WATER
BENZALKONIUM CHLORIDE
MICROCRYSTALLINE CELLULOSE
PHENYLETHYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-620-01 16 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077570 04/08/2019
FLUTICASONE
fluticasone spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-004(NDC:60432-264)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 50 ug
Inactive Ingredients
Ingredient Name Strength
WATER
POLYSORBATE 80
ANHYDROUS DEXTROSE
BENZALKONIUM CHLORIDE
PHENYLETHYL ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-004-16 1 SPRAY, METERED in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078492 01/01/2014
Labeler — Direct RX (079254320)
Establishment
Name Address ID/FEI Operations
Direct RX 079254320 relabel (61919-004), relabel (61919-620), relabel (61919-611)

Revised: 04/2019 Direct RX

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