United States· US:68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6
PAROXETINE
A medicinal product containing paroxetine hydrochloride hemihydrate, registered in United States by Lupin Pharmaceuticals, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Paroxetine hydrochloride hemihydrate in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaARKETISMedochemie Ltd., Limassol
- United KingdomParoxetine 10mg tabletsZentiva Pharma UK Ltd
- CanadaAG-PAROXETINE TABLETSANGITA PHARMA INC.
- SpainARAPAXEL 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGArafarma Group S.A.
- NetherlandsParmite druppels/drank 33,1 mg/mlSynthon B.V.
- ItalyDAPAGUTANGELINI S.P.A.
- BelgiumMerck-Paroxetine 20 mgPI Pharma
- FinlandHiemalixratiopharm GmbH
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/eefec603-7936-4bc5-874e-e810fa4d6179 GET /v1/drugs/eefec603-7936-4bc5-874e-e810fa4d6179?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.
{
"route": "ORAL",
"source": "ndc",
"strength": "12.5",
"substance": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"productndc": "68180-647",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA204134",
"marketing_category": "ANDA"
}See everything about paroxetine hydrochloride hemihydrate.
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.