DORZOLAMIDE HYDROCHLORIDE- dorzolamide hydrochloride solution 
FDC Limited

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Dorzolamide hydrochloride Ophthalmic Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DORZOLAMIDE HYDROCHLORIDE 
dorzolamide hydrochloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55545-1008
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1) DORZOLAMIDE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55545-1008-11 in 1 CARTON11/16/2019
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55545-1008-21 in 1 CARTON11/16/2019
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20529411/16/2019
Labeler - FDC Limited (650441301)
Registrant - FDC Limited (650078413)
Establishment
NameAddressID/FEIBusiness Operations
FDC Limited862267994analysis(55545-1008) , manufacture(55545-1008)

Revised: 11/2019
Document Id: 97618f4f-5891-0f06-e053-2995a90a3122
Set id: 751ced94-0ba7-46d8-b560-b9de57802284
Version: 2
Effective Time: 20191115
 
FDC Limited