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NDC 62332-0710-03 Olopatadine Hydrochloride 2 mg/mL Details

Olopatadine Hydrochloride 2 mg/mL

Olopatadine Hydrochloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Alembic Pharmaceuticals 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: 62332-0710-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	62332-0710
Product ID	62332-710_75823e5d-562a-43c2-8365-6f3f9484c9bf
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/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	2
Active Ingredient Units	mg/mL
Substance Name	OLOPATADINE HYDROCHLORIDE
Labeler Name	Alembic Pharmaceuticals 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	ANDA209420
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62332-0710-03 (62332071003)

Pricing Information	N/A
NDC Package Code	62332-710-03
Billing NDC	62332071003
Package	1 BOTTLE in 1 CARTON (62332-710-03) / 2.5 mL in 1 BOTTLE
Marketing Start Date	2021-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 75823e5d-562a-43c2-8365-6f3f9484c9bf Details

ACTIVE INGREDIENT(S)

Olopatadine 0.2%................ (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

Antihistamine

USE(S)

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 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 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 2°C to 25°C (36°F to 77°F)

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride, and water for Injection.

QUESTIONS?

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62332-710
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62332-710-03	1 in 1 CARTON	01/25/2021
1		2.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209420	01/25/2021

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Name	Address	ID/FEI	Business Operations
Establishment
Gland Pharma Limited		918601238	MANUFACTURE(62332-710)

Revised: 1/2021

Document Id: 75823e5d-562a-43c2-8365-6f3f9484c9bf

Set id: 75823e5d-562a-43c2-8365-6f3f9484c9bf

Version: 1

Effective Time: 20210125