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NDC 30142-0064-64 OLOPATADINE HYDROCHLORIDE 1 mg/mL Details

OLOPATADINE HYDROCHLORIDE 1 mg/mL

OLOPATADINE HYDROCHLORIDE is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Company. The primary component is OLOPATADINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Prescription ophthalmic olopatadine (Pazeo) and nonprescription ophthalmic olopatadine (Pataday) are used to relieve itchy eyes caused by allergic reactions to pollen, ragweed, grass, animal hair, or pet dander. Olopatadine is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause eye itching.

Related Packages: 30142-0064-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	30142-0064
Product ID	30142-064_54a3db8b-8ddb-468b-aa0f-8cad61ee643c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	OLOPATADINE HYDROCHLORIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	OLOPATADINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	1
Active Ingredient Units	mg/mL
Substance Name	OLOPATADINE HYDROCHLORIDE
Labeler Name	Kroger Company
Pharmaceutical Class	Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA204812
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0064-64 (30142006464)

Pricing Information	N/A
NDC Package Code	30142-064-64
Billing NDC	30142006464
Package	1 BOTTLE, PLASTIC in 1 CARTON (30142-064-64) / 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8993bc2-0fb3-4802-8187-3677d0e58026 Details

Drug Facts

Active ingredient

Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride, USP 0.111%)

Purpose

Antihistamine and Redness Reliever

Uses

temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product
to treat contact lens related irritation

When using this product

do not touch tip of container to any surface to avoid contamination
remove contact lenses before use
wait at least 10 minutes before reinserting contact lenses after use
do not wear a contact lens if your eye is red

Stop use and ask a doctor if you experience:

eye pain
changes in vision
increased redness of the eye
itching worsens or lasts for more than 72 hours

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 2 years of age and older:
- put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
- replace cap after each use
children under 2 years of age:

consult a doctor

Other information

only for use in the eye
store between 4° to 25°C (39° to 77°F)

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride and water for injection

Questions?

✆1-800-632-6900

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

NDC 30142-064-64

Kroger®

TWICE DAILY

Eye Allergy Itch &

Redness Relief

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.1%

Antihistamine and

Redness Reliever

STERILE

0.17 FL OZ

(5 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

COMPARE TO the active ingredient

in PATADAY® TWICE DAILY RELIEF

*See back panel

NDC 30142-064-64

Kroger®

NOW AVAILABLE without a prescription

Eye Allergy

Itch & Redness

Relief

Olopatadine Hydrochloride

Ophthalmic Solution

USP, 0.1%

Antihistamine and

Redness Reliever

TWICE

DAILY

Works

in Minutes

Relief from

Allergens:

Pet Dander, Pollen,

Grass, Ragweed

STERILE

0.17 FL OZ

(5 mL)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-064
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-064-64	1 in 1 CARTON	07/15/2020
1		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204812	07/15/2020

Labeler - Kroger Company (006999528)

Registrant - Aurobindo Pharma Limited (650082092)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650498244	ANALYSIS(30142-064) , MANUFACTURE(30142-064)

Revised: 1/2021

Document Id: 54a3db8b-8ddb-468b-aa0f-8cad61ee643c

Set id: f8993bc2-0fb3-4802-8187-3677d0e58026

Version: 4

Effective Time: 20210128