NDC Code 14445-405-10 - Dorzolamide Hydrochloride

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DORZOLAMIDE HYDROCHLORIDE(UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)	DORZOLAMIDE	20 mg in 1 mL
TIMOLOL MALEATE(UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)	TIMOLOL ANHYDROUS	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14445-405-10	1 in 1 CARTON	14/05/2021
1		10 mL in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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