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NDC 17478-0717-10 Ketotifen Fumarate 0.35 mg/mL Details

Ketotifen Fumarate 0.35 mg/mL

Ketotifen Fumarate is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is KETOTIFEN FUMARATE.

MedlinePlus Drug Summary

Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Related Packages: 17478-0717-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	17478-0717
Product ID	17478-717_730d47be-f8fa-45a4-829d-e8b43c850c44
Associated GPIs	86802040102010
GCN Sequence Number	043118
GCN Sequence Number Description	ketotifen fumarate DROPS 0.025 % OPHTHALMIC
HIC3	Q6R
HIC3 Description	EYE ANTIHISTAMINES
GCN	92451
HICL Sequence Number	006554
HICL Sequence Number Description	KETOTIFEN FUMARATE
Brand/Generic	Generic
Proprietary Name	Ketotifen Fumarate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ketotifen Fumarate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.35
Active Ingredient Units	mg/mL
Substance Name	KETOTIFEN FUMARATE
Labeler Name	Akorn
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077958
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17478-0717-10 (17478071710)

Pricing Information
NDC Package Code	17478-717-10
Billing NDC	17478071710
Package	1 BOTTLE, DROPPER in 1 CARTON (17478-717-10) / 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2007-10-01
NDC Exclude Flag	N
Price Per Unit	1.45648
Pricing Unit	ML
Effective Date	2022-11-23
NDC Description	KETOTIFEN FUM 0.025% EYE DROPS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-11-23

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 1376a697-bcf3-47a4-ba0d-8be7aa395c56 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

Antihistamine

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

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
replace cap after each use

Stop use and ask a doctor if you experience any of the following:

eye pain
changes in vision
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 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
Children under 3 years of age: Consult a doctor.

Other information

Only for use in the eye.
Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

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 17478-717-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Now OTC! NDC 17478-060-12

Akorn Logo

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-717
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen	0.35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
benzalkonium chloride (UNII: F5UM2KM3W7)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17478-717-10	1 in 1 CARTON	10/01/2007
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:17478-717-11	1 in 1 CARTON	09/30/2016	05/18/2022
2		10 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	ANDA077958	10/01/2007

Labeler - Akorn (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn AG		482198285	MANUFACTURE(17478-717) , ANALYSIS(17478-717) , PACK(17478-717) , LABEL(17478-717)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-717) , ANALYSIS(17478-717) , LABEL(17478-717) , PACK(17478-717) , STERILIZE(17478-717)

Revised: 9/2022

Document Id: 730d47be-f8fa-45a4-829d-e8b43c850c44

Set id: 1376a697-bcf3-47a4-ba0d-8be7aa395c56

Version: 9

Effective Time: 20220912

Search by Drug Name or NDC

NDC 17478-0717-10 Ketotifen Fumarate 0.35 mg/mL Details

Ketotifen Fumarate 0.35 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 17478-0717-10 (17478071710)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1376a697-bcf3-47a4-ba0d-8be7aa395c56 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

Do not use

When using this product

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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