United States· US:43353-713_85b2c456-e237-42da-aa5c-415dc3326154
Paroxetine
A medicinal product containing paroxetine hydrochloride hemihydrate, registered in United States by Aphena Pharma Solutions - Tennessee, LLC.
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
- Aphena Pharma Solutions - Tennessee, LLC
- 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 · 4
- ndc11433537131515 TABLET, FILM COATED in 1 BOTTLE (43353-713-15)
- ndc11433537134545 TABLET, FILM COATED in 1 BOTTLE (43353-713-45)
- ndc1143353-713-15
- ndc1143353-713-45
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.
- CzechiaPAROLEXHexal AG, Holzkirchen
- SpainARAPAXEL 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGArafarma Group S.A.
- FinlandHiemalixratiopharm GmbH
- FranceDEROXAT 20 mg, comprimé pelliculé sécableGLAXOSMITHKLINE
- SwitzerlandDeroxat
- PolandParoGenViatris Ltd
- BelgiumMerck-Paroxetine 20 mgPI Pharma
- NetherlandsParoxetine 20 mg, filmomhulde tablettenGenthon B.V.
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/b7a70fd7-128c-4e34-916d-e685a31a694e GET /v1/drugs/b7a70fd7-128c-4e34-916d-e685a31a694e?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": "20",
"substance": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"productndc": "43353-713",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA078406",
"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.