Zaditor ketotifen fumarate .25 mg/mL Solution — NDC 0065-4011-05 (Billing 00065-4011-05)
This is a package of Zaditor ketotifen fumarate .25 mg/mL Solution from Alcon Laboratories, Inc., marketed since Jan 2013 and currently FDA-listed; retail pharmacies pay about $2.23 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0065-4011-05 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0065 labeler · 4011 product · 05 package
- Package marketed since
- Mar 13, 2013
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0300654011057
- Medicaid fills, this package
- 10,099 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 043118
- GCN: 92451
- GPI-14 (Medi-Span): 86802040102011
- HICL (First Databank): 006554
- AHFS class code: 52:02.00.00
- RxCUI (RxNorm): 284380
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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.
Read the full MedlinePlus article ↗- It relieves or prevents itchy eyes from allergies. The drops give temporary relief from itching due to pollen, ragweed, grass, and animal hair and dander. The ACUVUE Theravision le...
- If you are an adult or a child 3 or older, use 1 drop in each affected eye twice a day, 8 to 12 hours apart. Don't use them more than twice daily. If your child is under 3, check w...
- Take your contact lenses out before using the drops. Then wait at least 10 minutes before putting them back in. If you use other eye products too, leave at least 5 minutes between...
- Stop the drops and talk to a doctor if you have eye pain, changes in vision, redness, or itching that gets worse or lasts more than 72 hours. With the ACUVUE Theravision lens, take...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.229 | $11.14 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.98 | $19.90 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00065-4011-05 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER | $2.23 / mL | $11.14 | 2013-03-13 | — | Active |
| 00065-4011-06 0065-4011-06 | 2 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER | $1.87 / mL | $18.70 | 2013-01-08 | — | Active |
| 00065-4011-11 0065-4011-11 | 3 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER | — | — | 2015-02-13 | — | Active |
Per mL, this pack runs about 19% above the cheapest pack (NDC 00065-4011-06, $1.87 vs $2.23 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 98% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Zaditor ketotifen fumarate .25 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketotifen Fumarate .25 mg/mL 00536-1252-40 | Rugby | 1 bottle | $1.294 | — | Availability likely | save 42% |
| Eye Itch Relief .25 mg/mL 70000-0522-01 | Cardinal | 1 bottle | $1.294 | — | Availability likely | save 42% |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 | Sentiss | 1 bottle | $1.294 | — | Availability likely | save 42% |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 | Armas | 1 bottle | $1.294 | — | Availability likely | save 42% |
| Ketotifen Fumarate .25 mg/mL 76385-0106-17 | Unichem | 1 bottle | $1.294 | — | Availability likely | save 42% |
| Eye Itch Relief .35 mg/mL 70000-0124-01 | CARDINAL | 1 bottle | $1.322 | — | FDA listed | save 41% |
| Alaway .25 mg/mL 24208-0601-05 | Bausch | 1 bottle | $2.083 | — | FDA listed | save 7% |
| Zaditor .25 mg/mLthis 00065-4011-05 | Alcon | 1 bottle | $2.229 | — | Availability likely | — |
| Eye Itch Relief .35 mg/mL 00363-0038-05 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 11673-0064-05 | Target | 1 bottle | — | — | FDA listed | — |
| Eye Itch Releif .25 mg/mL 11822-5533-01 | Rite | 1 bottle | — | — | Discontinued | — |
| Eye Itch Relief .25 mg/mL 21130-0601-05 | Safeway | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 30142-0398-05 | Kroger | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 36800-0097-05 | TOPCO | 1 bottle | — | — | FDA listed | — |
| Equate Eye Itch Relief .25 mg/mL 49035-0231-10 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate .25 mg/mL 50090-6472-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 50090-7253-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 50804-0601-05 | PERRIGO | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 67296-2245-05 | Redpharm | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 68788-4084-05 | Preferred | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate .25 mg/mL 68788-8715-05 | Preferred | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 69842-0275-05 | CVS | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate .35 mg/mL 71205-0115-05 | Proficient | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Ketotifen inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Alcon Laboratories, Inc. labeler code 00065
- Systane COMPLETE PF propylene glycol .06 mg/mL Emulsion NDC 0065-1509-28
- SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1510-00
- Systane COMPLETE PF propylene glycol .06 mg/mL Emulsion NDC 0065-1530-01
- BSS balanced salt solution 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL Solution NDC 0065-1795-04
- Systane Complete PF Propylene Glycol Emulsion .06 mg/mL Emulsion NDC 0065-2509-18
- Systane Pro PF Propylene Glycol 6 mg/mL Emulsion NDC 0065-3290-03
- SIMBRINZA brinzolamide/brimonidine tartrate 10 mg/mL; 2 mg/mL Suspension/ Drops NDC 0065-4147-25
- PATADAY TWICE A DAY RELIEF OLOPATADINE HYDROCHLORIDE 1 mg/mL Solution NDC 0065-4274-01
- GenTeal Tears Moderate Preservative Free dextran 70, hypromellose 2910 2910 (4000 MPA.S) 3 mg/mL; 70 1 mg/mL Solution/ Drops NDC 0065-8063-01
- GenTeal Tears Severe Hypromellose 2910 (4000 MPA.S) .003 g/g Gel NDC 0065-8064-01
- GenTeal Tears Gel Drops polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel NDC 0065-8067-01
- PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 2 mg/mL Solution NDC 0065-8150-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
⏱️ Dosage and Administration ▾
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
⚠️ Warnings ▾
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
🧪 Active Ingredient ▾
Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid
🎯 Purpose ▾
Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine
📄 When Using This Product ▾
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 ▾
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 ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Other Information ▾
Other information Only for use in the eye. Store between 4°-25°C (39°-77°F).
📄 Questions or Comments ▾
Questions? In the US, call toll-free 1-800-757-919 5 [email protected] www.systane.com Serious side effects associated with use of this product may be reported to this number.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Systane ® ZADITOR ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS EYE ITCH RELIEF Works in minutes Original prescription strength For ages 3 years and older up to 12 HOURS Alcon STERILE 30 DAY SUPPLY 5mL (0.17 FL OZ) Systane® ZADITOR® Original Prescription Strength Up to 12 Hour Itch Relief Works in Minutes For Ages 3 Years and Older 30 DAY SUPPLY TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.
Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Country of Origin: Italy 300048650-0821 ACTUAL SIZE LOT: EXP.: Systane ® ZADITOR ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS EYE ITCH RELIEF 5mL (0.17 FL OZ) STERILE Only for use in the eye. Store between 4° - 25°C (39° - 77°F).
TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. Manufactured by: Alcon Laboratories, Inc.
6201 South Freeway, Fort Worth, TX 76134 H15433-1018