NDC Code(s) : 14445-405-10
Packager : Indoco Remedies Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE ddorzolamide hydrochloride timolol maleate SOLUTION/ DROPS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:14445-405
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 ANHYDROUS - UNII:5JKY92S7BR) 		TIMOLOL ANHYDROUS5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:14445-405-101 in 1 CARTON 14/05/2021
110 mL in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202054 05/14/2021

LABELER - Indoco Remedies Limited (650445950)

Establishment
Name Address ID/FEI Business Operations
INDOCO REMEDIES LIMITED 915851870 ANALYSIS(14445-405), LABEL(14445-405), MANUFACTURE(14445-405), PACK(14445-405)

PRINCIPAL DISPLAY PANEL


NDC 14445-405-10.
Indoco Remedies Limited.
Dorzolamide HCl/ Timolol Maleat Ophthalmic Solution, USP, 22.3 mg/6.8 mg per mL.
10 ml in 10 ml bottle Container Label

Rx

2022

NDC 14445-405-10.
Indoco Remedies Limited.
Dorzolamide HCl/ Timolol Maleat Ophthalmic Solution, USP, 22.3 mg/6.8 mg per mL.

10 ml Carton Label

Rx

2022