OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION - olopatadine hydrochloride ophthalmic solution 
Gland Pharma Limited

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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
olopatadine-spl-shipper

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:68083-231
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68083-231-851000 in 1 CASE08/20/2020
12.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY08/20/2020
Labeler - Gland Pharma Limited (918601238)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238ANALYSIS(68083-231) , MANUFACTURE(68083-231) , PACK(68083-231)

Revised: 11/2022
Document Id: 95f3330f-8040-445b-a711-afeb48a909f2
Set id: 70233f0d-c170-4a1b-8c07-417e2c1e4e86
Version: 2
Effective Time: 20221110
 
Gland Pharma Limited