Zaditor ketotifen fumarate .25 mg/mL Solution
by Alcon Laboratories, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER
NDC 00065-4011-05
🏷️ FDA NDC (as labeled)
0065-4011-05
billing pads the labeler segment with a zero
This package
Contains5 mL in 1 bottle, dropper
Cost per mL$2.23 NADAC
Per package$11.13 / 5 ml
Pack sizes3 compare ↓
Also priced by: Medicaid pays $4.43/unit — full pricing hub ↓
OTC
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Past resolved recalls for this product (1)
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1317-2022
🆔 Identity & classification
FDA NDC (as labeled)
0065-4011-05
Product NDC
0065-4011
11-digit billing NDC
00065401105
NCPDP billing unit
ML — per mL (volume)
UNII
HBD503WORO
UPC
0300654011057
Application #
ANDA077200
SPL Set ID
ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Established class (EPC)
Histamine-1 Receptor Inhibitor
Mechanism of action
Histamine H1 Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2013-01-08
Route
OPHTHALMIC
Dosage form
SOLUTION
Substance
KETOTIFEN FUMARATE
GPI-14
86802040102011
GPI class
Zaditor
GCN Seq No
043118
GCN
92451
HICL code
006554
Ingredient (HICL)
Ketotifen Fumarate
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q6
Therapeutic class — intermediate (HIC2)
Ophthalmic Preparations
HIC3 code
Q6R
Therapeutic class — specific (HIC3)
Eye Antihistamines
AHFS code
52:02.00.00
AHFS class
Antiallergic Agents
FDB label name
ZADITOR 0.025% (0.035%) DROPS
FDB brand name
Zaditor
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0065-4011-05 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00065-4011-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Inhibitor class.
Pharmacologic class
Histamine-1 Receptor Inhibitor
Drug family (ATC)
Other antihistamines for systemic use, Other antiallergics
How it works
Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerAlcon Laboratories, Inc.
Application holderALCON PHARMACEUTICALS LTD
FDA applicationANDA077200 (ANDA)
Labeler code00065
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio55 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name ZADITOR 0.025% (0.035%) DROPS Ingredient Ketotifen Fumarate
📖 What it is MedlinePlus · NLM
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 ↗📗 Our plain-language guide HelloPharmacist
- Ketotifen blocks the histamine receptors in your eye that cause itching when you're exposed to allergens like pollen, pet dander, or grass. It also calms down the immune cells that...
- What exactly does ketotifen do for my eyes?
- You use ketotifen eye drops twice a day, about every 8 to 12 hours — no more than two times daily. Always remove your contact lenses before putting in the drops, and wait at least...
- How often do I use the eye drops, and can I use them with contacts in?
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about ketotifen fumarate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 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.
The official label also statesbenzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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 | $2.225 | $11.13 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $4.43 | $22.16 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 7% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketotifen Fumarate .25 mg/mL 00536-1252-40 | Rugby | 1 bottle | $1.304 | — | Availability likely | save 41% |
| Eye Itch Relief .25 mg/mL 70000-0522-01 | Cardinal | 1 bottle | $1.304 | — | Availability likely | save 41% |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 | Sentiss | 1 bottle | $1.304 | — | Availability likely | save 41% |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 | Armas | 1 bottle | $1.304 | — | Availability likely | save 41% |
| Ketotifen Fumarate .25 mg/mL 76385-0106-17 | Unichem | 1 bottle | $1.304 | — | Availability likely | save 41% |
| 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 6% |
| Zaditor .25 mg/mLthis 00065-4011-05 | Alcon | 1 bottle | $2.225 | — | 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 | — | — | FDA listed | — |
| 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 | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00065-4011-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
10.6K
Units reimbursed last 4 qtrs
58.6K
Gross reimbursed last 4 qtrs
$259.5K
Avg / prescription
$24.42
Avg / unit
$4.4314
Latest quarter Q4 2025
1.8KRx
Medicaid pays / mL
$4.4314
gross reimbursed
vs
NADAC / mL
$2.2251
acquisition cost
=
Spread
+$2.2063
+99% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 8,171 Rx Managed care · 2,457 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.9103
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 10,883 Rx · 60,346 units · $265,091 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00065-4011-05 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER | $2.23 / mL | $11.13 | 2013-03-13 | Active |
| 00065-4011-06 | 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER | $1.86 / mL | $18.65 | 2013-01-08 | Active |
| 00065-4011-11 | 3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 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, $1.86 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 NDC 00065-4011-05?
NDC 00065-4011-05 is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Zaditor ketotifen fumarate .25 mg/mL Solution?
Bill NDC 00065-4011-05 — the 11-digit billing format is 00065401105. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 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
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.