OLOPATADINE HYDROCHLORIDE 1 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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.
Read the full MedlinePlus article ↗- It does both, but with different products. The eye drops are for allergy-related itchy and red eyes. The nasal spray — brands like Patanase — is for seasonal allergic rhinitis, mea...
- What exactly does olopatadine treat — is it just for eyes, or can it help my runny nose too?
- You need to take your contacts out before you put the drops in. Wait at least 10 minutes after using the drops before you put them back in. Also, don't wear contacts at all if your...
- Can I wear my contact lenses while using olopatadine eye drops?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Olopatadine Hydrochloride — tap one for details:
Where does this data come from?
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.
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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.
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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.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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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.
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UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
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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.
6 inactive ingredients listed in the exact product block matched to this NDC.
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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $3.065 | $15.32 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| 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?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Eye Allergy Itch and Redness Relief 1 mg/mL 70000-0054-01 | CARDINAL | 1 bottle | $1.221 | — | Availability likely | save 60% |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 00536-1308-40 | Rugby | 1 bottle | $1.223 | — | Discontinued | save 60% |
| Olopatadine Hydrochloride 1 mg/mL 00536-1445-40 | RUGBY | 1 bottle | $1.268 | — | Availability likely | save 59% |
| olopatadine hydrochloride 1 mg/mL 16571-0882-05 | Rising | 5 ml | $1.268 | — | Availability likely | save 59% |
| Olopatadine Hydrochloride Ophthalmic 1 mg/mL 43598-0765-07 | Dr. | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Olopatadine Hydrochloride 1 mg/mL 46122-0672-64 | Amerisource | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Leader Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 70000-0717-01 | CARDINAL | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Olopatadine 1 mg/mL 70069-0017-01 | Somerset | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Olopatadine Hcl 1 mg/mL 70512-0520-05 | Sola | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Eye Allergy Itch and Redness Relief 1 mg/mL 70677-1156-01 | Strategic | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Olopatadine Hydrochloride 1 mg/mL 70677-1280-01 | Strategic | 1 bottle | $1.268 | — | Availability likely | save 59% |
| Pataday Twice A Day Relief 1 mg/mL 00065-4274-01 | Alcon | 1 bottle | $2.482 | — | Availability likely | save 19% |
| Olopatadine Hydrochloride 1 mg/mLthis 62332-0501-05 | Alembic | 1 bottle | $3.065 | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 00363-0200-40 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 00363-0867-01 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 00363-7130-05 | Walgreens | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 11673-0689-05 | Target | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 11822-0064-01 | RITE | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 11822-9976-05 | Rite | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 24208-0966-01 | Bausch | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 30142-0064-64 | Kroger | 1 bottle | — | — | FDA listed | — |
| Eye Allergy Itch and Redness Relief Twice Daily Relief 1 mg/mL 43598-0826-07 | Dr. | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 46122-0823-29 | AmerisourceBergen | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 46708-0709-05 | Alembic | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 50090-6341-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Olopatadine 1 mg/mL 50090-7959-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Olopatadine hydrochloride 1 mg/mL 51407-0663-05 | Golden | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 51407-0938-05 | Golden | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution Twice Daily 1 mg/mL 55910-0109-05 | DOLGENCORP, | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 58602-0006-40 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 58602-0009-40 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 58602-0012-40 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Olopatadine hydrochloride 1 mg/mL 60505-6221-00 | Apotex | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 62332-0709-05 | Alembic | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 63868-0822-05 | Chain | 1 bottle | — | — | FDA listed | — |
| olopatadine hydrochloride ophthalmic 1 mg/mL 68083-0477-01 | Gland | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 69168-0480-02 | Allegiant | 2 bottles | — | — | FDA listed | — |
| CVS Eye Allergy Itch Relief Twice Daily 1 mg/mL 69842-0268-05 | CVS | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 72036-0008-40 | Harris | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 72476-0852-64 | Retail | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 72657-0168-50 | GLENMARK | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 76162-0020-40 | TOPCO | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 79481-1000-01 | Meijer | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 79903-0000-40 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Equate Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 79903-0319-01 | WAL-MART | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 82442-0966-01 | TARGET | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 1 mg/mL 85766-0111-05 | Sportpharm | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
⏳ 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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62332-0501-05 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (62332-501-05) / 5 mL in 1 BOTTLE, PLASTIC | 2018-12-07 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Olopatadine hydrochloride ophthalmic solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.
⛔ Contraindications ▾
CONTRAINDICATIONS Olopatadine hydrochloride ophthalmic solution USP, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride, USP or any components of olopatadine hydrochloride ophthalmic solution USP, 0.1%.
⚠️ Warnings ▾
WARNINGS Olopatadine hydrochloride ophthalmic solution USP, 0.1% is for topical use only and not for injection or oral use.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritis, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.
🤰 Pregnancy ▾
PREGNANCY Pregnancy Category C. Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 93,750 times the MROHD and rabbits treated at 400 mg/kg/day, or 62,500 times the MROHD, during organogenesis showed a decrease in live fetuses.
There are, however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
🧒 Pediatric Use ▾
PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
🧓 Geriatric Use ▾
GERIATRIC USE No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H 1 -antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have low systemic exposure.
Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (<0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion.
Approximately 60-70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine. Results from an environmental study demonstrated that olopatadine hydrochloride ophthalmic solution USP, 0.1% was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks.
Results from conjunctival antigen challenge studies demonstrated that Olopatadine hydrochloride ophthalmic solution USP, 0.1% when subjects were challenged with antigen both initially and up to 8 hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied as follows: 5 mL in 5 mL screw neck white low density polyethylene bottle. 5 mL: NDC 62332-501-05 Storage : Store at 4° to 25°C (39° to 77°F) Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Manufactured by: Gland Pharma Limited D.P. Pally, Dundigal Post, Hyderabad-500 043, India Revised: 12/2018
📋 Description ▾
DESCRIPTION Olopatadine hydrochloride ophthalmic solution USP, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H 1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride, USP is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below: Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride Each mL of olopatadine hydrochloride ophthalmic solution USP, 0.1 % contains: Active : 1.11 mg olopatadine hydrochloride, USP equivalent to 1 mg olopatadine.
Preservative: Benzalkonium chloride 0.01%. Inactives: Dibasic sodium phosphate; Sodium chloride; Hydrochloric acid/Sodium hydroxide (adjust pH); and Water for Injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg. chemical-structure
💬 Information for Patients ▾
INFORMATION FOR PATIENTS To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. Patients should be advised not to wear a contact lens if their eye is red.
Olopatadine hydrochloride ophthalmic solution USP, 0.1% should not be used to treat contact lens related irritation. The preservative in Olopatadine hydrochloride ophthalmic solution USP, 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling Olopatadine hydrochloride ophthalmic solution USP, 0.1% before they insert their contact lenses.