Label: DORZOLAMIDE HYDROCHLORIDE solution
- NDC Code(s): 55545-1008-1, 55545-1008-2
- Packager: FDC Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 15, 2019
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INGREDIENTS AND APPEARANCE
DORZOLAMIDE HYDROCHLORIDE
dorzolamide hydrochloride solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55545-1008 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1) DORZOLAMIDE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55545-1008-1 1 in 1 CARTON 11/16/2019 1 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55545-1008-2 1 in 1 CARTON 11/16/2019 2 10 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205294 11/16/2019 Labeler - FDC Limited (650441301) Registrant - FDC Limited (650078413) Establishment Name Address ID/FEI Business Operations FDC Limited 862267994 analysis(55545-1008) , manufacture(55545-1008)
