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NDC 17478-0312-12 Olopatadine 2 mg/mL Details

Olopatadine 2 mg/mL

Olopatadine is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. 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: 17478-0312-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	17478-0312
Product ID	17478-312_4df9962a-31a1-454d-9e4a-a86927409e5e
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
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	Akorn
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	ANDA204723
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17478-0312-12 (17478031212)

Pricing Information	N/A
NDC Package Code	17478-312-12
Billing NDC	17478031212
Package	1 BOTTLE, DROPPER in 1 CARTON (17478-312-12) / 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 138f0f62-c5d2-457c-8a29-c44fd84aefde Details

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 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 the 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 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 at 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?

Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-312-12

Olopatadine HCl Ophthalmic

Solution, USP 0.2%

Antihistamine

ONCE DAILY

STERILE 2.5 mL (0.085 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Original NDC 17478-312-12

Prescription

Strength Akorn logo

Olopatadine

HCl Ophthalmic

Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

ONCE DAILY

STERILE

2.5 mL (0.085 FL OZ)

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

OLOPATADINE

olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-312
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
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:17478-312-12	1 in 1 CARTON	09/01/2021
1		2.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204723	09/01/2021

OLOPATADINE

olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-305
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
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:17478-305-11	2 in 1 CARTON	09/01/2021
1		2.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204723	09/01/2021

Labeler - Akorn (117696770)

Registrant - AKORN OPERATING COMPANY LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	LABEL(17478-312, 17478-305) , MANUFACTURE(17478-312, 17478-305) , PACK(17478-312, 17478-305) , ANALYSIS(17478-312, 17478-305) , STERILIZE(17478-312, 17478-305)

Revised: 2/2022

Document Id: 4df9962a-31a1-454d-9e4a-a86927409e5e

Set id: 138f0f62-c5d2-457c-8a29-c44fd84aefde

Version: 2

Effective Time: 20220203

Search by Drug Name or NDC

NDC 17478-0312-12 Olopatadine 2 mg/mL Details

Olopatadine 2 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 17478-0312-12 (17478031212)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 138f0f62-c5d2-457c-8a29-c44fd84aefde Details

Active ingredient

Purpose

Use

Warnings

Do not use

When using the product

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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