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NDC 79903-0001-39 OLOPATADINE HYDROCHLORIDE 2 mg/mL Details

OLOPATADINE HYDROCHLORIDE 2 mg/mL

OLOPATADINE HYDROCHLORIDE is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. 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: 79903-0001-39
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	79903-0001
Product ID	79903-001_0c3d13c1-95fd-4bf6-ac9d-cf0b801b8568
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	2
Active Ingredient Units	mg/mL
Substance Name	OLOPATADINE HYDROCHLORIDE
Labeler Name	Wal-Mart Stores, Inc.
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	ANDA209995
Listing Certified Through	2024-12-31

Package

Package Images

NDC 79903-0001-39 (79903000139)

Pricing Information	N/A
NDC Package Code	79903-001-39
Billing NDC	79903000139
Package	1 BOTTLE, PLASTIC in 1 CARTON (79903-001-39) / 2.5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 34723580-dfd0-4ab7-a757-d86570261e7f Details

Drug Facts

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine

Use

temporarily relieves itchy 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) once daily, no more than once 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, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection

Questions?

✆1-888-287-1915

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

NDC 79903-001-39

equateTM

Olopatadine Hydrochloride

Ophthalmic Solution USP, 0.2%

Antihistamine

EYE ALLERGY ITCH RELIEF

Sterile 2.5 mL (0.085 FL OZ)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

NDC 79903-001-39

equateTM

Compare to Pataday® Once Daily Relief active ingredient*

NOW AVAILABLE

WITHOUT A PRESCRIPTION

Olopatadine

Hydrochloride

Ophthalmic Solution

USP, 0.2%

Antihistamine

EYE ALLERGY ITCH RELIEF

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen

• Grass • Ragweed

ONCE DAILY

STERILE

2.5 mL (0.085 FL OZ)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack

2 PACK

NDC 79903-001-41

equateTM

Compare to Pataday® Once Daily Relief active ingredient*

NOW AVAILABLE

WITHOUT A PRESCRIPTION

Olopatadine

Hydrochloride

Ophthalmic Solution

USP, 0.2%

Antihistamine

EYE ALLERGY ITCH RELIEF

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen

• Grass • Ragweed

ONCE DAILY

STERILE

2 x 2.5 mL Bottles

(0.085 FL OZ EACH)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79903-001
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79903-001-39	1 in 1 CARTON	07/15/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:79903-001-41	2 in 1 CARTON	07/15/2020
2		2.5 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	ANDA209995	07/15/2020

Labeler - Wal-Mart Stores, Inc. (051957769)

Revised: 9/2021

Document Id: 0c3d13c1-95fd-4bf6-ac9d-cf0b801b8568

Set id: 34723580-dfd0-4ab7-a757-d86570261e7f

Version: 4

Effective Time: 20210920