United States· US:45802-759_14ed3375-f9ec-40bf-8529-cafc44c46f28
Promethazine Hydrochloride
A medicinal product containing promethazine hydrochloride, registered in United States by Padagis Israel Pharmaceuticals Ltd.
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
- PROMETHAZINE HYDROCHLORIDE
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- 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
- ndc1145802-759-30
- ndc11458027593012 BLISTER PACK in 1 CARTON (45802-759-30) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-759-00)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Promethazine hydrochloride in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomPhenergan 10mg tabletsOpella Healthcare UK Ltd
- GermanyAtosilDesitin Arzneimittel Gmbh
- NetherlandsPromethazine ACE 25 mg/ml, oplossing voor injectieACE Pharmaceuticals B.V.
- SwedenFarghess 25 mg Filmdragerad tablettOmet Pharma AB
- Japanプロメタジン塩酸塩田辺ファーマ
- NorwayPhenerganOrifarm AS
- PolandDipherganBausch Health Ireland Ltd.
- FrancePHENERGAN 2 %, crèmeLABORATOIRES FRILAB
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Bulgaria · Aнтиалeрзин
- Cyprus · Promethazine Remedica
- Czechia · Prothazin
- Germany · Atosil, Atosil N
- Denmark · Phenergan, Prometazin Actavis
- Spain · Fenergan
- France · Phenergan
- United Kingdom (Northern Ireland) · Phenergan, Phenergan Elixir
- Greece · Fenimezyl, Prugal-Derm
- Hungary · Pipolphen
- Ireland · Phenergan
- Iceland · Phenergan, Prometazin Actavis
- Italy · Alontan Antistaminico, Fadezin
- Malta · Fenazil, Promethazine Remedica
- Netherlands · Promethazine Ace, Promethazine Cf
- Norway · Phenergan
- Poland · Diphergan, Polfergan
- Portugal · Prometazina Basi, Prometazina Medlink
- Sweden · Farghess, Lergigan
- Slovakia · Prothazin
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/ed834e8c-0097-43a7-9969-b48739fb19b0 GET /v1/drugs/ed834e8c-0097-43a7-9969-b48739fb19b0?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": "RECTAL",
"source": "ndc",
"strength": "25",
"substance": "PROMETHAZINE HYDROCHLORIDE",
"productndc": "45802-759",
"dosage_form": "SUPPOSITORY",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA040500",
"marketing_category": "ANDA"
}See everything about promethazine hydrochloride.
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.