United States· US:55289-037_3465ea08-4468-da4e-e063-6294a90a11b5

Paroxetine

A paroxetine product containing paroxetine hydrochloride hemihydrate, registered in United States by PD-Rx Pharmaceuticals, Inc.. The same ATC class is registered in 19 of our 19 countries.

ATC N06AB05Orange 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…normalisedParoxetineATCN06AB05REGISTER NO.US:55289-037_3465ea08…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Paroxetine is registered in 19 of 19 countries.

Countries holding a registration under ATC N06AB05 (paroxetine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 11 of them publish a price we can compare per daily dose

Paroxetine · ATC N06AB05

19 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • 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.

Price per daily dose

What a daily dose of paroxetine costs, country by country.

Normalised to the WHO defined daily dose (20 mg), the median price runs from $0.18 in France to $1.04 in Switzerland — a ×5.8 gap.

  • 3 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Paroxetine · price per daily dose (20 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$1.04
  • IT Italy$0.26
  • FR France$0.18
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
paroxetine hydrochloride hemihydrate
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Country
United States (US)
ATC code
N06AB05
ATC class
Paroxetine
Defined daily dose
20 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    5528903745
    45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-037-45)
  • ndc11
    5528903790
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-037-90)

Regulatory notes

UNII (FDA substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
A078902
ABABABAB
DailyMed SPL labels
1 version tracked

Interactions

505 interactions on record for paroxetine.

Graded by severity as the source publishes them — 26 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

Paroxetine · interactions on record

505 records

  • 26 severe
  • 193 moderate
  • 2 minor
  • 209 info

Most severe, free to view

  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • DolasetronA04AA04severe
  • PalonosetronA04AA05severe

75 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Paroxetine in 17 other countries

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

All paroxetine products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Ennos, Paroxat
  • Belgium · Paroxetine Ab, Paroxetine Eg
  • Bulgaria · Ксетанор, Парикс
  • Cyprus · Afentral, Arketis
  • Czechia · Arketis, Parolex
  • Germany · Euplix, Paroxat
  • Denmark · Euplix, Euplix Dråber, Orale Dråber, Opløsning
  • Estonia · Arketis, Paroxetin Actavis
  • Spain · Daparox, Frosinor
  • Finland · Optipar, Paroxetin Orion
  • France · Deroxat, Divarius
  • United Kingdom (Northern Ireland) · Paroxetine, Paroxetine Activase Pharmaceuticals
  • Greece · Paroxia, Seroxat
  • Croatia · Paroksetin Pharmas, Seroxat
  • Hungary · Paretin, Parogen
  • Ireland · Parox, Seroxat
  • Iceland · Paxetin Teva, Seroxat
  • Italy · Arzinka, Dapagut
  • Lithuania · Arketis, Paroxetin Actavis
  • Luxembourg · Paroxetine Eg, Paroxetine Viatris
  • Latvia · Arketis, Paroxetin Actavis
  • Malta · Arketis, Paroxetine Aurobindo
  • Netherlands · Parmite, Paroxetine Cf
  • Norway · Paroxetine Oresund Pharma, Seroxat
  • Poland · Arketis, Parogen
  • Portugal · Dropax, Paroxetina Alter Genéricos
  • Romania · Arketis, Paroxetină Teva
  • Sweden · Parocetan, Paroxetin Hexal
  • Slovenia · Paroxat, Seroxat
  • Slovakia · Arketis, Paretin

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/f549e643-1602-42be-b806-1b4fde80b922
GET /v1/drugs/f549e643-1602-42be-b806-1b4fde80b922?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": "X2ELS050D8",
    "rxcui": "1298842",
    "inchikey": "MQZOATSIFWSKKT-OASXIEIISA-N",
    "display_name": "PAROXETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 2
  },
  "spl_meta": {
    "e63fe922-b35a-406c-8737-f3f5e6d5a30d": {
      "match": "brand_token",
      "title": "PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "17",
      "published_date": "2026-06-01"
    }
  },
  "productid": "55289-037_3465ea08-4468-da4e-e063-6294a90a11b5",
  "productndc": "55289-037",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078902",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 13, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE",
  "proprietary_name": "Paroxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078902",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride hemihydrate",
  "start_marketing_date": "20080324",
  "active_numerator_strength": "10"
}

See everything about paroxetine.

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.