United States· US:63187-305_4b42b2f4-a013-4b16-bc3e-d9c3b503beed
Loratadine and Pseudoephedrine
A medicinal product containing loratadine; pseudoephedrine sulfate, registered in United States by Proficient Rx LP.
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
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Manufacturer
- Proficient Rx LP
- 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 · 2
- ndc1163187-305-10
- ndc1163187305101 BLISTER PACK in 1 CARTON (63187-305-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Loratadine; pseudoephedrine sulfate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaCLARITIN ALLERGY + SINUS EXTRA STRENGTHBAYER INC
- CzechiaCLARINASE REPETABSBAYER s.r.o., Praha
- PolandClaritine ActiveBayer Sp. z o.o.
- SpainCLARITYNE PLUS 10mg/240mg COMPRIMIDOS DE LIBERACION PROLONGADABayer Hispania S.L.
- FinlandClarinaseSchering-Plough Europe
- IcelandClarinaseBayer AB
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Austria · Clarinase
- Belgium · Clarinase Once Daily, Clarinase Repetabs
- Bulgaria · Клариназе
- Cyprus · Clarityne-D
- Czechia · Clarinase Repetabs
- Denmark · Clarinase
- Spain · Clarityne Plus, Narine Repetabs
- Greece · Clarityne-D
- Croatia · Clarinase
- Iceland · Clarinase
- Malta · Clarinase Repetabs
- Poland · Claritine Active, Claritine Duo
- Portugal · Claridon
- Romania · Clarinase
- Slovenia · Claritine Kombo
- Slovakia · Clarinase Repetabs
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/af0dee7f-f32a-46d4-9541-d1f57d7c667e GET /v1/drugs/af0dee7f-f32a-46d4-9541-d1f57d7c667e?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": "10; 240",
"substance": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"productndc": "63187-305",
"dosage_form": "TABLET, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA076557",
"marketing_category": "ANDA"
}See everything about loratadine; pseudoephedrine sulfate.
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.