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Olopatadine 2 mg/mL Solution/ Drops, 2 bottles

by Akorn · 2 BOTTLE, DROPPER in 1 CARTON (17478-305-11) / 2.5 mL in 1 BOTTLE, DROPPER
NDC 17478-0305-11
🏷️ FDA NDC (as labeled) 17478-305-11 billing pads the product segment with a zero
This package
Contains2 bottles Pack sizes2 compare ↓
Also comes in: 2.5 mL 17478-0305-12
OTC Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 17478-305-11
Product NDC 17478-305
11-digit billing NDC 17478030511
Application # ANDA204723
SPL Set ID 7de7f9ea-53e3-4f03-b60d-31a2817b5f49
Established class (EPC) Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance OLOPATADINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 17478-305-11 — 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 → 17478-0305-11. 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.

🏭 Manufacturer & labeler

LabelerAkorn
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA204723 (ANDA)
Labeler code17478
Product typeHuman Otc Drug
Portfolio3 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

📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Olopatadine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Olopatadine Hydrochloride — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Olopatadine Hydrochloride (3 interactions) — ranked by severity →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 systemPer mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2.5 mL
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

ProductLabelerPackNADAC/unitTEStatusPrice 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/mL 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 2 mg/mLthis 17478-0305-11 Akorn 2 bottles — — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
17478-0305-12 1 BOTTLE, DROPPER in 1 CARTON (17478-305-12) / 2.5 mL in 1 BOTTLE, DROPPER $8.41 / mL $21.03 2017-12-05 Inactivated by FDA
17478-0305-11 You're viewing this 2 BOTTLE, DROPPER in 1 CARTON (17478-305-11) / 2.5 mL in 1 BOTTLE, DROPPER — — 2021-09-01 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 17478-0305-11?
NDC 17478-0305-11 contains 2 bottles — 2 bottle, dropper in 1 carton / 2.5 ml in 1 bottle, dropper.
What is the difference between NDC 17478-0305-11 and NDC 17478-0305-12?
Both are Olopatadine 2 mg/mL Solution/ Drops — the drug itself is identical. NDC 17478-0305-11 is the 2 bottles package, while NDC 17478-0305-12 is the 1 bottle package.
What NDC number is used to bill for this package of Olopatadine 2 mg/mL Solution/ Drops?
Bill NDC 17478-0305-11 — the 11-digit billing format is 17478030511. 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.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 17478-305-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 17478-0305-11, written without dashes as 17478030511. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 17478-0305-11, the first segment (17478) is the labeler code FDA assigned to Akorn; the middle segment (0305) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (17478-0305-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Akorn is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 47 words ▾

1 INDICATIONS AND 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. ( 1 )

⏱️ Dosage and Administration 33 words ▾

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. ( 2 )

💊 Dosage Forms and Strengths 30 words ▾

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. ( 3 )

⛔ Contraindications 3 words ▾

4 CONTRAINDICATIONS None.

⚠️ Warnings and Cautions 164 words ▾

5 WARNINGS AND PRECAUTIONS For topical ocular use only. Not for injection or oral use. ( 5.1 )

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.

🤒 Adverse Reactions 114 words ▾

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 Akorn, Inc. at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~1 min read ▾

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 136 words ▾

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 19 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology 178 words ▾

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% solution 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 to 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 26 words ▾

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 53 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is supplied in a 10 mL white, low density polyethylene (LDPE) bottle with a dropper tip, and a white polypropylene cap in the following size: NDC 17478-305-12 2.5 mL in 10 mL bottle STORAGE: Store at 4° to 25°C (39° to 77°F).

📦 Storage and Handling 9 words ▾

STORAGE: Store at 4° to 25°C (39° to 77°F).

📋 Description 122 words ▾

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 C 21 H 23 NO 3 • HCl. 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, 0.2% contains: Active: 2.22 mg Olopatadine Hydrochloride 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. Chemical Structure

💬 Information for Patients 143 words ▾

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 used 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, 0.2% benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%. Rx only AKORN Manufactured by: Akorn, Inc .

Lake Forest, IL 60045 OLP00N Rev. 12/17

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 17445-6034-00 · Sigma-Aldrich 17504-0007-02 · Lonza →
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.