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KETOTIFEN FUMARATE .25 mg/mL Solution — NDC 76385-0106-17 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

KETOTIFEN FUMARATE .25 mg/mL Solution — NDC 76385-106-17 (Billing 76385-0106-17)

by Unichem Pharmaceuticals (USA), Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

This is a package of KETOTIFEN FUMARATE .25 mg/mL Solution from Unichem Pharmaceuticals (USA), Inc., marketed since Oct 2021 and currently FDA-listed; retail pharmacies pay about $1.29 per mL (NADAC). It is this product's only package size.

NDC 76385-0106-17
🏷️ FDA NDC (as labeled) 76385-106-17 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 76385-106-17 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76385 labeler · 106 product · 17 package
Package marketed since
Oct 15, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7638510617 1
Medicaid fills, this package
77,400 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76385-106-17
Product NDC 76385-106
11-digit billing NDC 76385010617
NCPDP billing unit ML — per mL (volume)
RxCUI 311237
UNII HBD503WORO
Application # ANDA204059
SPL Set ID 0fe119ad-cb44-4e90-a096-0ed0ba63dc31
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 2021-10-15
Route OPHTHALMIC
Dosage form SOLUTION
Substance KETOTIFEN FUMARATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86802040102011
GPI class Ketotifen Fumarate
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 KETOTIFEN 0.025% (0.035%) DROP
FDB brand name Ketotifen Fumarate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • 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): 311237
Why two NDCs? The FDA registers this code as 76385-106-17 — a 5-3-2 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 product segment → 76385-0106-17. 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.

Clinical

Label name KETOTIFEN 0.025% (0.035%) DROP Ingredient Ketotifen Fumarate
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Ketotifen guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.294 $6.47 / 5 ml
Medicaid paysCMS SDUD · 12 mo $2.58 $12.89 / 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
Feb 2022 Sep 2022 Jan 2026 Sep 2026 $1.537 $1.279
▼ Down 2% over the last 23 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76385-0106-17 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC 2021-10-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketotifen Fumarate .25 mg/mL 00536-1252-40 Rugby 1 bottle $1.294 — Availability likely —
Eye Itch Relief .25 mg/mL 70000-0522-01 Cardinal 1 bottle $1.294 — Availability likely —
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 Sentiss 1 bottle $1.294 — Availability likely —
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 Armas 1 bottle $1.294 — Availability likely —
Ketotifen Fumarate .25 mg/mLthis 76385-0106-17 Unichem 1 bottle $1.294 — Availability likely —
Eye Itch Relief .35 mg/mL 70000-0124-01 CARDINAL 1 bottle $1.322 — FDA listed +2%
Alaway .25 mg/mL 24208-0601-05 Bausch 1 bottle $2.083 — FDA listed +61%
Zaditor .25 mg/mL 00065-4011-05 Alcon 1 bottle $2.229 — Availability likely +72%
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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

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.

4 inactive ingredients listed in the exact product block matched to this NDC.

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.

Manufacturer & labeler

LabelerUnichem Pharmaceuticals (USA), Inc.
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA204059 (ANDA)
Labeler code76385
First marketedOct 2021
Product typeHuman Otc Drug
Portfolio210 products on file

More NDCs from Unichem Pharmaceuticals (USA), Inc. labeler code 76385

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.

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 66 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76385-106-17 Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS 5 mL (0.17 FL OZ) Sterile ketotifenfumaratelabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76385-106-17 Now OTC Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS Eye Itch Relief Works in Minutes Original Prescription Strength for ages 3 years and older 20 day supply 5 mL (0.17 FL OZ) Sterile ketotifenfumaratecarton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
77.4K
Units reimbursed last 4 qtrs
437.6K
Gross reimbursed last 4 qtrs
$1.13M
Avg / prescription
$14.58
Avg / unit
$2.5784
Latest quarter Q1 2026
4.1KRx
Medicaid pays / mL
$2.5784
gross reimbursed
vs
NADAC / mL
$1.2940
acquisition cost
=
Spread
+$1.2844
+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 ⓘ
58% FFS 42% MCO
Fee-for-service · 44,545 Rx Managed care · 32,855 Rx
State Medicaid map
Alaska: no data reported AK Maine: 270 units · 19.4 per 100k residents ME Washington: 5,125 units · 65.6 per 100k residents WA Idaho: no data reported ID Montana: 185 units · 16.3 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,193 units · 73.1 per 100k residents MN Wisconsin: 1,028 units · 17.4 per 100k residents WI Michigan: 9,580 units · 95.4 per 100k residents MI New York: 131,463 units · 672 per 100k residents NY Vermont: 130 units · 20.1 per 100k residents VT New Hampshire: 245 units · 17.5 per 100k residents NH Oregon: 505 units · 11.9 per 100k residents OR Nevada: 6,413 units · 201 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 870 units · 6.9 per 100k residents IL Indiana: 4,106 units · 59.8 per 100k residents IN Ohio: 20,375 units · 173 per 100k residents OH Pennsylvania: 17,689 units · 136 per 100k residents PA New Jersey: 50,297 units · 541 per 100k residents NJ Massachusetts: 21,998 units · 314 per 100k residents MA California: 100,010 units · 257 per 100k residents CA Utah: no data reported UT Colorado: 840 units · 14.3 per 100k residents CO Nebraska: 755 units · 38.2 per 100k residents NE Missouri: no data reported MO Kentucky: 6,646 units · 147 per 100k residents KY West Virginia: 2,115 units · 119 per 100k residents WV Virginia: 7,855 units · 90.1 per 100k residents VA Maryland: 14,050 units · 227 per 100k residents MD Connecticut: 235 units · 6.5 per 100k residents CT Rhode Island: 2,595 units · 237 per 100k residents RI Arizona: 7,345 units · 98.8 per 100k residents AZ New Mexico: 170 units · 8.0 per 100k residents NM Kansas: 280 units · 9.5 per 100k residents KS Arkansas: 1,025 units · 33.4 per 100k residents AR Tennessee: 705 units · 9.9 per 100k residents TN North Carolina: no data reported NC South Carolina: 3,668 units · 68.3 per 100k residents SC Delaware: 95 units · 9.2 per 100k residents DE Oklahoma: 640 units · 15.8 per 100k residents OK Louisiana: no data reported LA Mississippi: 145 units · 4.9 per 100k residents MS Alabama: no data reported AL Georgia: 8,885 units · 80.6 per 100k residents GA D.C.: 2,681 units · 395 per 100k residents DC Hawaii: 1,100 units · 76.7 per 100k residents HI Texas: 1,295 units · 4.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2672
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
🏆 Top states by units · per 100k residents
1 New York 672 /100k
2 New Jersey 541 /100k
3 D.C. 395 /100k
4 Massachusetts 314 /100k
5 California 257 /100k
6 Rhode Island 237 /100k
7 Maryland 227 /100k
8 Nevada 201 /100k
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.
← 76385-0102-01 · Unichem 76385-0107-01 · Unichem →
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.