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NDC 58602-0013-39 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 Aurohealth LLC. 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: 58602-0013-39
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	58602-0013
Product ID	58602-013_223ca879-71fd-4a04-94d1-ae8aae206948
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	Aurohealth LLC
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 58602-0013-39 (58602001339)

Pricing Information	N/A
NDC Package Code	58602-013-39
Billing NDC	58602001339
Package	1 BOTTLE, PLASTIC in 1 CARTON (58602-013-39) / 2.5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5f9e93e7-ff12-484d-add8-4f834193c1c6 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?

✆1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/13/2010

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

PrimaryHealth NDC 58602-013-39

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 58602-013-39

                                                            PrimaryHealth

                              *Compare to the Active Ingredient

                                    in Pataday® Once Daily Relief

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                     ONCE

• Grass • Ragweed                          DAILY

                                                     STERILE

                                  2.5 mL (0.085 FL OZ)

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

Twin Pack

                                                      NDC 58602-013-41

PrimaryHealth

                              *Compare to the Active Ingredient

                                     in Pataday® Once Daily Relief

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                      ONCE

• Grass • Ragweed                          DAILY

                                                     STERILE

                                     Two 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:58602-013
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:58602-013-39	1 in 1 CARTON	07/15/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:58602-013-41	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 - Aurohealth LLC (078728447)

Registrant - Aurobindo Pharma Limited (650082092)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650498244	ANALYSIS(58602-013) , MANUFACTURE(58602-013)

Revised: 10/2020

Document Id: 223ca879-71fd-4a04-94d1-ae8aae206948

Set id: 5f9e93e7-ff12-484d-add8-4f834193c1c6

Version: 3

Effective Time: 20201009