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NDC 68001-0530-69 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 BluePoint Laboratories. 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: 68001-0530-69
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	68001-0530
Product ID	68001-530_dbd299b7-11c8-bf59-e053-2a95a90a2cd4
Associated GPIs	86802065102030
GCN Sequence Number	062065
GCN Sequence Number Description	olopatadine HCl DROPS 0.2 % OPHTHALMIC
HIC3	Q6R
HIC3 Description	EYE ANTIHISTAMINES
GCN	97848
HICL Sequence Number	012815
HICL Sequence Number Description	OLOPATADINE HCL
Brand/Generic	Generic
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	BluePoint Laboratories
Pharmaceutical Class	Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209995
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68001-0530-69 (68001053069)

Pricing Information
NDC Package Code	68001-530-69
Billing NDC	68001053069
Package	1 BOTTLE, PLASTIC in 1 CARTON (68001-530-69) / 2.5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2022-04-08
NDC Exclude Flag	N
Price Per Unit	3.04937
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	OLOPATADINE HCL 0.2% EYE DROP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL dbd28ee2-bbb5-a4b1-e053-2a95a90afff4 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 2° to 25°C (36° 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

Manufactured by:

Eugia Pharma Specialities Limited, Unit III

IDA, Pashamylaram – 502307, TS., India.

Code: TS/DRUGS/13/2010

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

NDC 68001-520-69

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 68001-530-69

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

2.5 mL (0.085 FL OZ)

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-530
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:68001-530-69	1 in 1 CARTON	04/08/2022
1		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	04/08/2022

Labeler - BluePoint Laboratories (985523874)

Name	Address	ID/FEI	Business Operations
Establishment
Eugia Pharma Specialities Limited		650498244	analysis(68001-530) , manufacture(68001-530)

Revised: 4/2022

Document Id: dbd299b7-11c8-bf59-e053-2a95a90a2cd4

Set id: dbd28ee2-bbb5-a4b1-e053-2a95a90afff4

Version: 1

Effective Time: 20220408