NDC Code(s) : 54569-1224-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-1224(NDC:24208-720)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
CREATININE(UNII: AYI8EX34EU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYDROCHLORIC ACID(UNII: QTT17582CB)
PHENYLETHYL ALCOHOL(UNII: ML9LGA7468)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
SODIUM BISULFITE(UNII: TZX5469Z6I)
SODIUM BORATE(UNII: 91MBZ8H3QO)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-1224-01 in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040069 07/26/1996

PRINCIPAL DISPLAY PANEL

NDC 54569-1224-0

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


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