Label: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution
- NDC Code(s): 68083-231-85
- Packager: Gland Pharma Limited
- Category: BULK INGREDIENT
Drug Label Information
Updated November 10, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BULK LABEL
NDC 68083-231-85
Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.2%
Quantity- 1000 - 2.5 mL BottlesBatch 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 solutionProduct 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)