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NDC 62332-0709-05 Olopatadine Hydrochloride 1 mg/mL Details

Olopatadine Hydrochloride 1 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: 62332-0709-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	62332-0709
Product ID	62332-709_3b330307-f5b5-473f-a4dd-56a080a1b518
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	1
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	ANDA209919
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62332-0709-05 (62332070905)

Pricing Information	N/A
NDC Package Code	62332-709-05
Billing NDC	62332070905
Package	1 BOTTLE in 1 CARTON (62332-709-05) / 5 mL in 1 BOTTLE
Marketing Start Date	2021-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bd1f9779-d048-46ff-a570-ce3ad92715e7 Details

ACTIVE INGREDIENT(S)

Olopatadine (0.1%).........(equivalent to olopatadine hydrochloride 0.111%)

PURPOSE

Antihistamine and redness reliever

USE(S)

temporarily relieves itchy 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 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) 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°C to 25°C (39°F 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?

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

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label:

Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label:

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE

olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62332-709
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 (UNII: GR686LBA74)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62332-709-05	1 in 1 CARTON	02/18/2021
1		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	ANDA209919	02/18/2021

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Name	Address	ID/FEI	Business Operations
Establishment
Gland Pharma Limited		918601238	MANUFACTURE(62332-709)

Revised: 2/2021

Document Id: 3b330307-f5b5-473f-a4dd-56a080a1b518

Set id: bd1f9779-d048-46ff-a570-ce3ad92715e7

Version: 3

Effective Time: 20210219