NDC Code(s) : 66993-190-20
Packager : Prasco Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

dorzolamide hydrochloride-timolol maleatedorzolamide hydrochloride and timolol maleate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-190
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORZOLAMIDE HYDROCHLORIDE(UNII: QZO5366EW7)
(DORZOLAMIDE - UNII:9JDX055TW1) 		DORZOLAMIDE20 mg in 1 mL
TIMOLOL MALEATE(UNII: P8Y54F701R)
(TIMOLOL - UNII:817W3C6175) 		TIMOLOL5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
MANNITOL(UNII: 3OWL53L36A)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-190-201 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020869 04/07/1998

PRINCIPAL DISPLAY PANEL

10 mL

NDC 66993-190-20

OCUMETER® PLUS OPHTHALMIC DISPENSER
STERILE OPHTHALMIC SOLUTION

Dorzolamide Hydrochloride and Timolol
Maleate Ophthalmic Solution

(Dorzolamide Hydrochloride 22.3 mg/mL
Timolol Maleate 6.8 mg/mL)

Rx only

PRASCO

Manuf. for: Prasco Laboratories, Mason, OH 45040 USA
Manuf. by: Laboratoires Merck Sharp & Dohme-Chibret
Clermont Ferrand Cedex 9, 63963, France Made in France

OCUMETER is a registered trademark of
Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

PRINCIPAL DISPLAY PANEL - 10 mL Carton