👁️image loading
(from DailyMed)

Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL Solution, 1000 bottles — NDC 43598-764-10 (Billing 43598-0764-10)

by Dr. Reddy's Laboratories Inc. · 1000 BOTTLE, PLASTIC in 1 CASE / 2.5 mL in 1 BOTTLE, PLASTIC

This is a package of 1,000 bottles of Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL Solution from Dr. Reddy's Laboratories Inc., marketed since Sep 2020 and currently FDA-listed.

NDC 43598-0764-10
🏷️ FDA NDC (as labeled) 43598-764-10 billing pads the product segment with a zero
This package
Contains1000 bottles Pack sizes3 compare ↓
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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-764-10
Product NDC 43598-764
11-digit billing NDC 43598076410
RxCUI 1111343
UNII 2XG66W44KF
Application # ANDA209752
SPL Set ID f249d79e-0f62-d2f1-bcbc-22dda253aad2
Established class (EPC) Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
Mechanism of action Histamine H1 Receptor Antagonists
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-01
Route OPHTHALMIC
Dosage form SOLUTION
Substance OLOPATADINE HYDROCHLORIDE

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

GPI-14 86802065102030
GPI class Olopatadine HCl
GCN Seq No 062065
GCN 97848
HICL code 012815
Ingredient (HICL) Olopatadine Hcl
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 OLOPATADINE HCL 0.2% EYE DROP
FDB brand name Olopatadine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 062065
  • GCN: 97848
  • GPI-14 (Medi-Span): 86802065102030
  • HICL (First Databank): 012815
  • AHFS class code: 52:02.00.00
  • RxCUI (RxNorm): 1111343
Why two NDCs? The FDA registers this code as 43598-764-10 — 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 → 43598-0764-10. 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, Histamine-1 Receptor Antagonist, Mast Cell Stabilizer
Drug family (ATC) Antiallergic agents, excl. corticosteroids, 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 OLOPATADINE HCL 0.2% EYE DROP Ingredient Olopatadine Hcl
📗 Our plain-language guide HelloPharmacist
  • The eye drops relieve itchy eyes from allergies, and some products relieve redness too. The nasal spray relieves seasonal allergic rhinitis symptoms in adults and children 6 and ol...
  • It depends on the product. Some eye drops are twice daily, 6 to 8 hours apart, and others once daily. The nasal spray is twice daily. Follow your label or prescriber.
  • Take your lenses out before using the drops and wait at least 10 minutes before putting them back. Don't wear lenses if your eyes are red. These drops aren't for contact lens irrit...
  • With the nasal spray, a bitter taste, headache, nosebleeds and sore throat are common. It can also make you drowsy, so be careful driving and skip alcohol.
📖 Read our full Olopatadine guide →
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 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 2 bottles
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 Per unit Per pack Marketing startMarketing endStatus
43598-0764-02 43598-764-02 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC $2.96 / mL $7.41 2020-09-01 — Active
43598-0764-25 43598-764-25 2 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC — — 2020-09-01 — Active
43598-0764-10 You're viewing this 1000 BOTTLE, PLASTIC in 1 CASE / 2.5 mL in 1 BOTTLE, PLASTIC — — — — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1000 bottles — 1000 bottle, plastic in 1 case / 2.5 ml in 1 bottle, plastic.
How does this package differ from NDC 43598-0764-02?
Both are Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL Solution — the drug itself is identical. This page's package is the 1000 bottles one, while NDC 43598-0764-02 is the 1 bottle package.
What NDC number is used to bill for this package of Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Olopatadine Hydrochloride 2 mg/mL 24208-0617-01 Bausch 1 bottle $1.983 — Availability likely —
Leader Olopatadine Hydrochloride 2 mg/mL 70000-0716-01 CARDINAL 1 bottle $1.983 — Availability likely —
Olopatadine Hydrochloride 2 mg/mL 00536-1307-23 Rugby 1 bottle $2.964 — Availability likely —
olopatadine hydrochloride 2 mg/mL 16571-0861-25 Rising 2.5 ml $2.964 — Availability likely —
Olopatadine Hydrochloride 2 mg/mL 46122-0671-27 Amerisource 1 bottle $2.964 — Availability likely —
Olopatadine Hydrochloride 2 mg/mL 68001-0530-69 BluePoint 1 bottle $2.964 — Availability likely —
Olopatadine Hydrochloride 2 mg/mL 68001-0674-92 BluePoint 1 bottle $2.964 — Availability likely —
Olopatadine Hydrochloride 2 mg/mL 70069-0491-01 Somerset 1 bottle $2.964 — Availability likely —
Eye Allergy Itch Relief Once Daily Relief 2 mg/mL 70677-1155-01 Strategic 1 bottle $2.964 — Availability likely —
Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL 83324-0120-25 Chain 1 bottle $2.964 — 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 —
Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mLthis 43598-0764-10 Dr. 1000 bottles — — 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 —
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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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.

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.

Manufacturer & labeler

LabelerDr. Reddy's Laboratories Inc.
Application holderGLAND PHARMA LTD
FDA applicationANDA209752 (ANDA)
Labeler code43598
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio160 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.

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 14 words ▾

USE temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

⏱️ Dosage and Administration 56 words ▾

DIRECTIONS adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily, no more than once per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor

⚠️ Warnings 5 words ▾

WARNINGS For external use only

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENT Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)

🧪 Inactive Ingredients 22 words ▾

INACTIVE INGREDIENTS Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Edetate disodium, Hydrochloric acid/Sodium hydroxide (adjust pH), Povidone, Sodium chloride, and Water for Injection.

🎯 Purpose 2 words ▾

PURPOSE Antihistamine

📄 Do Not Use 26 words ▾

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

📄 When Using This Product 43 words ▾

WHEN USING THIS PRODUCT do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red

📄 Stop Use and Ask a Doctor If 27 words ▾

STOP USE AND ASK DOCTOR IF you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours

📄 Keep Out of Reach of Children 19 words ▾

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL NDC 68083-231-01 Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% Bottle Label: Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% C arton Label:

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

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.
1 bottle43598-0764-02 25,390 Rx · $440,212
2 bottles43598-0764-25 No Medicaid data
Drug total (last 4 qtrs): 25,390 Rx · 72,793 units · $440,212 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Olopatadine Hydrochloride Ophthalmic Solution (this brand).

Top reported reactions

Treatment Failure1,933
Nausea117
Headache116
Diarrhoea114
Fatigue103
Pneumonia103
Pyrexia102

Reporter sex

4,003 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization774
Death192
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,938 132
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (43598-0764-02), 2 bottles (43598-0764-25). 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?
Dr. Reddy's Laboratories Inc. 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.
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.