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, GLAND PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BULK LABEL

NDC: 68083-398-85

Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.7%.

Quantity- 1,000 - 2.5 mL fill Bottles

Batch No. : AXXXXXXX

Exp. 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: 68083-398
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYDROXYPROPYL .GAMMA.-CYCLODEXTRIN (UNII: P6BYU725IU)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68083-398-85	1000 in 1 CASE	01/06/2026
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		01/06/2026

Labeler - Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Business Operations
GLAND PHARMA LIMITED		918601238	ANALYSIS(68083-398) , MANUFACTURE(68083-398) , PACK(68083-398)