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NDC 00363-0200-40 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 WALGREEN CO.. 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: 00363-0200-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	00363-0200
Product ID	0363-0200_ee463951-4b99-4232-b427-25667231747e
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	WALGREEN CO.
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 00363-0200-40 (00363020040)

Pricing Information	N/A
NDC Package Code	0363-0200-40
Billing NDC	00363020040
Package	1 BOTTLE, PLASTIC in 1 CARTON (0363-0200-40) / 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 637cb721-53bf-4938-80a6-5760980098eb 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?

✆1-800-925-4733

Distributed by:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Made in India

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

Walgreens

NDC 0363-0200-40

Eye Allergy Itch & Redness Relief

OLOPATADINE HYDROCHLORIDE OPHTHALMIC

SOLUTION USP, 0.1%

ANTIHISTAMINE & REDNESS RELIEVER

Twice Daily 5 mL (0.17 FL OZ)

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

ORIGINAL PRESCRIPTION STRENGTH

                                         NDC 0363-0200-40

Walgreens

Compare to the active ingredient in

Pataday® Twice Daily Relief††

Eye Allergy Itch

& Redness Relief

Relief

OLOPATADINE HYDROCHLORIDE

OPHTHALMIC SOLUTION USP, 0.1%

ANTIHISTAMINE & REDNESS RELIEVER

TWICE DAILY

• Works in minutes

• Relief from allergens:

    pet dander, grass,

    pollen & ragweed

• Sterile

5 mL (0.17 FL OZ)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0200
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:0363-0200-40	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 - WALGREEN CO. (008965063)

Registrant - EUGIA Pharma Specialities Limited (650804896)

Name	Address	ID/FEI	Business Operations
Establishment
Eugia Pharma Specialities Limited		650498244	ANALYSIS(0363-0200) , MANUFACTURE(0363-0200)

Revised: 11/2021

Document Id: ee463951-4b99-4232-b427-25667231747e

Set id: 637cb721-53bf-4938-80a6-5760980098eb

Version: 4

Effective Time: 20211111