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United States· US:70069-491_f19c5298-b566-4416-a345-c5334c6a7ad7

OLOPATADINE HYDROCHLORIDE

A olopatadine product containing olopatadine hydrochloride, registered in United States by Somerset Therapeutics, LLC. The same ATC class is registered in 2 of our 19 countries.

ATC R01AC08Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedOLOPATADINE HYDROCHLORIDEATCR01AC08REGISTER NO.US:70069-491_f19c5298…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about olopatadine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Olopatadine is registered in 2 of 19 countries.

Countries holding a registration under ATC R01AC08 (olopatadine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 1 of them publish a price we can compare per daily dose
Search olopatadine products by name

Olopatadine · ATC R01AC08

2 / 19 countries

  • Japan
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Olopatadine Hydrochloride
Manufacturer
Somerset Therapeutics, LLC
Country
United States (US)
ATC code
R01AC08
ATC class
Olopatadine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    7006949101
    2.5 mL in 1 BOTTLE, PLASTIC (70069-491-01)

Regulatory notes

UNII (FDA substance ID)
2XG66W44KF
OLOPATADINE HYDROCHLORIDE
RxCUI 236599
Orange Book
A215006
DailyMed SPL labels
1 version tracked

Interactions

454 interactions on record for olopatadine.

Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check olopatadine against other medicinesHow interaction checks work

Olopatadine · interactions on record

454 records

  • 2 severe
  • 310 moderate
  • 142 info

Most severe, free to view

  • Sodium oxybateN01AX11severe
  • DicycloverineA03AA07moderate
  • AtropineA03BA01moderate
  • HyoscyamineA03BA03moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Olopatadine in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All olopatadine products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Olopatadin Micro Labs, Olopatadin Unimed Pharma
  • Bulgaria · Оловижън, Олопатадин Унимед Фарма
  • Cyprus · Alopatan, Olopatadine Rafarm
  • Czechia · Olopatadine Unimed Pharma, Olopatidine Olikla
  • Germany · Alltrevo, Olopatadin Actrevo
  • Denmark · Olopatadin Brown & Burk, Olopatadin Juta
  • Estonia · Olopatadine Unimed Pharma
  • Spain · Apadin, Olopatadina Abamed
  • United Kingdom (Northern Ireland) · Olopatadine Blumont Pharma, Olopatadine Brown & Burk Uk
  • Greece · Alopatan, Olopatadine Rafarm
  • Croatia · Olopatadin
  • Hungary · Olopatadine Unimed Pharma
  • Ireland · Olopatadine Brown & Burk
  • Iceland · Opatanol
  • Italy · Calmira®, Olonet
  • Liechtenstein · Opatanol
  • Lithuania · Olopatadine Unimed Pharma
  • Latvia · Olopatadine Unimed Pharma
  • Malta · Olopatadine Unimed Pharma
  • Netherlands · Olopatadine Brown & Burk, Optamont
  • Norway · Olopatadine Sandoz, Opatanol
  • Poland · Oftahist, Olodon Free
  • Portugal · Olopatadina Stallpharma
  • Romania · Olopatadina Brown & Burk, Olopatadină Rompharm
  • Sweden · Olopatadin Evolan, Olopatadin Orifarm
  • Slovenia · Olopatadin Unimed Pharma
  • Slovakia · Olopatadine Olikla, Olopatadine Unimed Pharma

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/29e0c2e9-4ef3-4f7b-bf17-7b31879f06ac
GET /v1/drugs/29e0c2e9-4ef3-4f7b-bf17-7b31879f06ac?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "2XG66W44KF",
    "rxcui": "236599",
    "inchikey": "HVRLZEKDTUEKQH-NOILCQHBSA-N",
    "display_name": "OLOPATADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "96ad3623-f7cc-4c1c-aa65-d89077873b69": {
      "match": "brand_token",
      "title": "OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [RUGBY LABORATORIES]",
      "spl_version": "4",
      "published_date": "2026-05-22"
    }
  },
  "productid": "70069-491_f19c5298-b566-4416-a345-c5334c6a7ad7",
  "productndc": "70069-491",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "215006",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.2% BASE",
        "product_no": "001",
        "approval_date": "Dec 18, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "OLOPATADINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215006",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olopatadine Hydrochloride",
  "start_marketing_date": "20241220",
  "active_numerator_strength": "2"
}
API referenceMCP serverPlans

See everything about olopatadine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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