OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution

Olopatadine Hydrochloride Ophthalmic Solution by

Drug Labeling and Warnings

Olopatadine Hydrochloride Ophthalmic Solution by is a Other medication manufactured, distributed, or labeled by Gland Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BULK LABEL

NDC: 68083-231-85

Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.2%

Quantity- 1000 - 2.5 mL Bottles

Batch No. :

Mfg. Date :

Repack

Before :

Expiration Date : MM/YYYY

Store at 2°-25°C (36°-77°F)

CAUTION: For Manufacturing, processing or repackaging only.

Manufactured by :

Gland Pharma Limited 

D.P. Pally, Hyderabad - 500043, INDIA

Code: AP/DRUGS/103/97

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 68083-231
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68083-231-85	1000 in 1 CASE	08/20/2020
1		2.5 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		08/20/2020

Labeler - Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	ANALYSIS(68083-231) , MANUFACTURE(68083-231) , PACK(68083-231)