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NDC 58602-0012-40 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 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: 58602-0012-40
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	58602-0012
Product ID	58602-012_8fb16daa-340d-45a0-ab22-e028d77e2476
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	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	ANDA204812
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0012-40 (58602001240)

Pricing Information	N/A
NDC Package Code	58602-012-40
Billing NDC	58602001240
Package	1 BOTTLE, PLASTIC in 1 CARTON (58602-012-40) / 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8fb16daa-340d-45a0-ab22-e028d77e2476 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?

✆1-855-274-44122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/13/2010

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

PrimaryHealth NDC 58602-012-40

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

STERILE 5 mL (0.17 FL OZ)

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

                                                      NDC 58602-012-40

                                                            PrimaryHealth

                              *Compare to the Active Ingredient

                                     in Pataday® Once Daily Relief

NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     TWICE

• Grass • Ragweed                          DAILY

                                                     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:58602-012
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:58602-012-40	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 - Aurohealth LLC (078728447)

Registrant - Aurobindo Pharma Limited (650082092)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650498244	ANALYSIS(58602-012) , MANUFACTURE(58602-012)

Revised: 8/2020

Document Id: 8fb16daa-340d-45a0-ab22-e028d77e2476

Set id: 8fb16daa-340d-45a0-ab22-e028d77e2476

Version: 1

Effective Time: 20200821