👁️image loading
(from DailyMed)

Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL Solution/ Drops

by Rugby Laboratories · 1 BOTTLE, PLASTIC in 1 CARTON (0536-1308-40) / 5 mL in 1 BOTTLE, PLASTIC
NDC 00536-1308-40
🏷️ FDA NDC (as labeled) 0536-1308-40 billing pads the labeler segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. 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) 0536-1308-40
Product NDC 0536-1308
11-digit billing NDC 00536130840
NCPDP billing unit ML — per mL (volume)
RxCUI 1111339
UNII 2XG66W44KF
Application # ANDA209619
SPL Set ID d7bcba63-bfaf-240b-199e-2e42a91c19c9
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 Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2021-01-05
Marketing end 2026-06-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance OLOPATADINE HYDROCHLORIDE
GPI-14 86802065102020
GPI class Olopatadine HCl
GCN Seq No 030796
GCN 68321
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 0.1% EYE DROPS
FDB brand name Olopatadine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1308-40 — a 4-4-2 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 labeler segment → 00536-1308-40. 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.

🏭 Manufacturer & labeler

LabelerRugby Laboratories
Application holderGLAND PHARMA LTD
FDA applicationANDA209619 (ANDA)
Labeler code00536
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio149 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

Label name OLOPATADINE HCL 0.1% EYE DROPS Ingredient Olopatadine Hcl
📖 What it is MedlinePlus · NLM

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 ↗
📗 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 →
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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 $1.223 $6.11 / 5 ml
Medicaid paysCMS SDUD · 12 mo $2.93 $14.67 / 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
Dec 2021 Jul 2022 Feb 2024 Jun 2026 $1.704 $1.165
▼ Down 18% over the last 21 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eye Allergy Itch and Redness Relief 1 mg/mL 70000-0054-01 CARDINAL 1 bottle $1.221 Availability likely +0%
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mLthis 00536-1308-40 Rugby 1 bottle $1.223 Discontinued
Olopatadine Hydrochloride 1 mg/mL 00536-1445-40 RUGBY 1 bottle $1.268 Availability likely +4%
olopatadine hydrochloride 1 mg/mL 16571-0882-05 Rising 5 ml $1.268 Availability likely +4%
Olopatadine Hydrochloride Ophthalmic 1 mg/mL 43598-0765-07 Dr. 1 bottle $1.268 Availability likely +4%
Olopatadine Hydrochloride 1 mg/mL 46122-0672-64 Amerisource 1 bottle $1.268 Availability likely +4%
Leader Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 70000-0717-01 CARDINAL 1 bottle $1.268 Availability likely +4%
Olopatadine 1 mg/mL 70069-0017-01 Somerset 1 bottle $1.268 Availability likely +4%
Olopatadine Hcl 1 mg/mL 70512-0520-05 Sola 1 bottle $1.268 Availability likely +4%
Eye Allergy Itch and Redness Relief 1 mg/mL 70677-1156-01 Strategic 1 bottle $1.268 Availability likely +4%
Olopatadine Hydrochloride 1 mg/mL 70677-1280-01 Strategic 1 bottle $1.268 Availability likely +4%
Pataday Twice A Day Relief 1 mg/mL 00065-4274-01 Alcon 1 bottle $2.482 Availability likely +103%
Olopatadine Hydrochloride 1 mg/mL 62332-0501-05 Alembic 1 bottle $3.065 FDA listed +151%
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
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
Jan 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.

🗺️ 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 00536-1308-40, 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 – Q4 2025 · 4 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
68.6K
Units reimbursed last 4 qtrs
361.2K
Gross reimbursed last 4 qtrs
$1.06M
Avg / prescription
$15.45
Avg / unit
$2.9342
Latest quarter Q4 2025
13.2KRx
Medicaid pays / mL
$2.9342
gross reimbursed
vs
NADAC / mL
$1.2228
acquisition cost
=
Spread
+$1.7114
+140% 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
74% FFS 26% MCO
Fee-for-service · 50,978 Rx Managed care · 17,611 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,220 units · 159 per 100k residents ME Washington: no data reported WA Idaho: 850 units · 43.3 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 6,491 units · 113 per 100k residents MN Wisconsin: 5,625 units · 95.2 per 100k residents WI Michigan: 6,238 units · 62.2 per 100k residents MI New York: 146,450 units · 748 per 100k residents NY Vermont: 625 units · 96.6 per 100k residents VT New Hampshire: 70 units · 5.0 per 100k residents NH Oregon: 840 units · 19.8 per 100k residents OR Nevada: 1,875 units · 58.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 3,765 units · 54.9 per 100k residents IN Ohio: 12,890 units · 109 per 100k residents OH Pennsylvania: 27,099 units · 209 per 100k residents PA New Jersey: 8,212 units · 88.4 per 100k residents NJ Massachusetts: 60 units · 0.9 per 100k residents MA California: 95,230 units · 244 per 100k residents CA Utah: no data reported UT Colorado: 1,545 units · 26.3 per 100k residents CO Nebraska: 1,680 units · 84.9 per 100k residents NE Missouri: 4,770 units · 77.0 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 5,205 units · 59.7 per 100k residents VA Maryland: 4,041 units · 65.4 per 100k residents MD Connecticut: 4,675 units · 129 per 100k residents CT Rhode Island: 1,295 units · 118 per 100k residents RI Arizona: 1,010 units · 13.6 per 100k residents AZ New Mexico: no data reported NM Kansas: 2,795 units · 95.1 per 100k residents KS Arkansas: no data reported AR Tennessee: 2,515 units · 35.3 per 100k residents TN North Carolina: 2,695 units · 24.9 per 100k residents NC South Carolina: no data reported SC Delaware: 2,035 units · 197 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 500 units · 4.5 per 100k residents GA D.C.: 735 units · 108 per 100k residents DC Hawaii: no data reported HI Texas: 4,580 units · 15.0 per 100k residents TX Florida: 2,580 units · 11.4 per 100k residents FL
Units reimbursed · per 100k residents
0.9748
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 748 /100k
2 California 244 /100k
3 Pennsylvania 209 /100k
4 Delaware 197 /100k
5 Maine 159 /100k
6 Connecticut 129 /100k
7 Rhode Island 118 /100k
8 Minnesota 113 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1308-40 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (0536-1308-40) / 5 mL in 1 BOTTLE, PLASTIC 2021-01-05 Discontinued by firm

🧭 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) ✓ Available
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) ✓ Available
“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

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 0536-1308-40, 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: 00536-1308-40, written without dashes as 00536130840. 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 00536-1308-40, the first segment (00536) is the labeler code FDA assigned to Rugby Laboratories; the middle segment (1308) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Rugby Laboratories 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 16 words

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

⏱️ Dosage and Administration 66 words

DIRECTIONS • adults and children 2 years of age and older: • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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 (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

🧪 Inactive Ingredients 23 words

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

🎯 Purpose 5 words

PURPOSE Antihistamine and redness reliever

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