OLOPATADINE HYDROCHLORIDE 2 mg/mL Solution/ Drops, 1 bottle
🆔 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 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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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 FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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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.
8 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 |
|---|---|---|---|---|---|---|
| Olopatadine Hydrochloride 2 mg/mL 24208-0617-01 | Bausch | 1 bottle | $2.005 | — | Availability likely | — |
| Leader Olopatadine Hydrochloride 2 mg/mL 70000-0716-01 | CARDINAL | 1 bottle | $2.005 | — | Availability likely | — |
| Olopatadine Hydrochloride 2 mg/mL 00536-1307-23 | Rugby | 1 bottle | $2.997 | — | Availability likely | — |
| olopatadine hydrochloride 2 mg/mL 16571-0861-25 | Rising | 2.5 ml | $2.997 | — | Availability likely | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 43598-0764-02 | Dr. | 1 bottle | $2.997 | — | Availability likely | — |
| Olopatadine Hydrochloride 2 mg/mL 46122-0671-27 | Amerisource | 1 bottle | $2.997 | — | Availability likely | — |
| Olopatadine Hydrochloride 2 mg/mL 68001-0530-69 | BluePoint | 1 bottle | $2.997 | — | Availability likely | — |
| Olopatadine Hydrochloride 2 mg/mL 68001-0674-92 | BluePoint | 1 bottle | $2.997 | — | Availability likely | — |
| Olopatadine Hydrochloride 2 mg/mL 70069-0491-01 | Somerset | 1 bottle | $2.997 | — | Availability likely | — |
| Eye Allergy Itch Relief Once Daily Relief 2 mg/mL 70677-1155-01 | Strategic | 1 bottle | $2.997 | — | Availability likely | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 83324-0120-25 | Chain | 1 bottle | $2.997 | — | Availability likely | — |
| Eye Allergy Itch Relief 2 mg/mL 70000-0053-01 | CARDINAL | 1 bottle | $3.096 | — | Availability likely | — |
| Pataday Once Daily Relief 2 mg/mL 00065-8150-01 | Alcon | 1 bottle | $5.893 | — | Availability likely | — |
| Olopatadine Hydrochloride 2 mg/mL 00363-0869-01 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 00363-7131-25 | Walgreens | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 00363-8022-39 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 11673-0688-25 | Target | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 11822-0063-02 | RITE | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 11822-9975-02 | Rite | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 21130-0105-02 | Albertsons | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 24208-0967-01 | Bausch | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 30142-0026-27 | Kroger | 1 bottle | — | — | FDA listed | — |
| Once Daily Relief 2 mg/mL 37808-0045-25 | H | 1 bottle | — | — | FDA listed | — |
| Eye Allergy Itch Relief Once Daily Relief 2 mg/mL 43598-0827-02 | Dr. | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 46122-0824-29 | AmerisourceBergen | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 46708-0710-03 | Alembic | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 50090-5613-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Eye Drops 2 mg/mL 51316-0675-25 | CVS | 1 bottle | — | — | FDA listed | — |
| Retaine Allergy 5 mg/2.5mL 54799-0920-25 | OCuSOFT | 2.5 ml | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution Once Daily 2 mg/mL 55910-0137-25 | DOLGENCORP, | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 58602-0007-39 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 58602-0010-39 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 58602-0013-39 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| Olopatadine hydrochloride 2 mg/mL 60505-6222-02 | Apotex | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mLthis 62332-0502-03 | Alembic | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 62332-0710-03 | Alembic | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 63868-0821-25 | Chain | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 63941-0024-39 | Best | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic 2 mg/mL 68083-0231-01 | Gland | 1 bottle | — | — | FDA listed | — |
| Eye Allergy Itch Relief 2 mg/mL 69168-0495-77 | Allegiant | 2 bottles | — | — | FDA listed | — |
| CVS Eye Allergy Itch Relief Once Daily 2 mg/mL 69842-0269-25 | CVS | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 72036-0009-39 | Harris | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 72476-0851-21 | Retail | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 72657-0194-11 | GLENMARK | 2 bottles | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 73581-0709-02 | YYBA | 2 bottles | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 76162-0044-39 | TOPCO | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 79481-1001-02 | Meijer | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 79903-0001-39 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Equate Olopatadine Hydrochloride 2 mg/mL 79903-0318-01 | WAL-MART | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 80539-0001-39 | Allwell | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 82442-0967-02 | TARGET | 1 bottle | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 73581-0712-02 | YYBA | 2 bottles | — | — | FDA listed | — |
| Olopatadine Hydrochloride 2 mg/mL 73581-0713-02 | YYBA | 2 bottles | — | — | 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 |
|---|---|---|---|
| 62332-0502-03 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (62332-502-03) / 2.5 mL in 1 BOTTLE, PLASTIC | 2019-04-29 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONSAND USAGE Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis. Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dose is one drop in each affected eye once a day. The recommended dose is one drop in each affected eye once a day.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution 0.2%: each ml contains 2.22 mg of olopatadine hydrochloride. Ophthalmic solution 0.2%: each ml contains 2.22 mg of olopatadine hydrochloride.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS
5.1For topical ocular use only. Not for injection or oral use.
5.2Contamination of Tip and Solution As with any eye drop, 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.
5.3Contact Lens Use Patients should be advised not to wear a contact lens if their eye is red. Olopatadine hydrochloride ophthalmic solution USP, 0.2% should not be used to treat contact lens related irritation. The preservative in Olopatadine hydrochloride ophthalmic solution USP 0.2%, 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, 0.2% before they insert their contact lenses. For topical ocular use only. Not for injection or oral use (5.1).
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus. Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.
Some of these events were similar to the underlying disease being studied. Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic effects: Pregnancy Category C Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight.
Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. 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.
8.3Nursing Mothers Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when olopatadine hydrochloride ophthalmic solution USP, 0.2% is administered to a nursing mother.
8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic effects: Pregnancy Category C Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight.
Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. 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 ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
12.3Pharmacokinetics Systemic bioavailability data upon topical ocular administration of olopatadine hydrochloride ophthalmic solution USP, 0.2% are not available. Following topical ocular administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was shown to have a 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 elimination half-life in plasma following oral dosing was 8 to 12 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.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Olopatadine hydrochloride ophthalmic solution USP, 0.2% is supplied in a 5 mL screw neck white bottle with nozzle made with low density polyethylene and white color screw cap made with high density polyethylene Tamper evidence is provided with a tamper evident ring around the closure and neck area of the package. 2.5 mL fill in 5 mL bottle (NDC 62332-502-03) Storage Store at 2°C to 25°C (36°F to 77°F)
📋 Description ▾
11 DESCRIPTION Olopatadine hydrochloride ophthalmic solution USP, 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88 and a molecular formula of C21H23NO3 • HCl. The chemical structure is presented below: Chemical Name: 11-[(Z)-3(Dimethylamino) propylidene]-6-11dihydrodibenz[b,e] oxepin-2-acetic acid, hydrochloride Each mL of olopatadine hydrochloride ophthalmic solution USP, 0.2% contains: Active : 2.22 mg olopatadine hydrochloride, USP equivalent to 2 mg olopatadine.
Inactives: Povidone; Dibasic sodium phosphate; Sodium chloride; Edetate disodium; Benzalkonium chloride 0.01% ( preservative ); 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. olopatadine-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Topical Ophthalmic Use Only For topical ophthalmic administration only.
17.2Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
17.3Concomitant Use of Contact Lenses Patients should be advised not to wear a contact lens if their eyes are red. Patients should be advised that olopatadine hydrochloride ophthalmic solution USP, 0.2% should not be use to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of olopatadine hydrochloride ophthalmic solution USP, 0.2%.
The preservative in olopatadine hydrochloride ophthalmic solution, USP benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration