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United States· US:50090-4813_4639fbda-1925-4364-a4b2-75605a688fcf

Promethazine Hydrochloride

A promethazine product containing promethazine hydrochloride, registered in United States by A-S Medication Solutions. The same ATC class is registered in 14 of our 19 countries.

ATC R06AD02US 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…normalisedPromethazine HydrochlorideATCR06AD02REGISTER NO.US:50090-4813_4639fbd…PACKS LISTED10CHECKEDSeptember 27, 2026

Where it is registered

Promethazine is registered in 14 of 19 countries.

Countries holding a registration under ATC R06AD02 (promethazine), each read from that country’s own register.

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

Promethazine · ATC R06AD02

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PROMETHAZINE HYDROCHLORIDE
Manufacturer
A-S Medication Solutions
Country
United States (US)
ATC code
R06AD02
ATC class
Promethazine
Defined daily dose
25 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 10

  • ndc11
    5009048130
    12 TABLET in 1 BOTTLE (50090-4813-0)
  • ndc11
    5009048131
    10 TABLET in 1 BOTTLE (50090-4813-1)
  • ndc11
    5009048135
    60 TABLET in 1 BOTTLE (50090-4813-5)
  • ndc11
    5009048136
    20 TABLET in 1 BOTTLE (50090-4813-6)
  • ndc11
    5009048139
    30 TABLET in 1 BOTTLE (50090-4813-9)
  • ndc11
    50090-4813-0
  • ndc11
    50090-4813-1
  • ndc11
    50090-4813-5
  • ndc11
    50090-4813-6
  • ndc11
    50090-4813-9

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

976 interactions on record for promethazine.

Graded by severity as the source publishes them — 87 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

Promethazine · interactions on record

976 records

  • 87 severe
  • 625 moderate
  • 19 minor
  • 245 info

Most severe, free to view

  • MetoclopramideA03FA01severe
  • CisaprideA03FA02severe
  • DolasetronA04AA04severe
  • Potassium chlorideA12BA01severe
  • 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

Promethazine in 16 other countries

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

All promethazine products

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/c07d9485-1b8e-41fa-9e49-e1c63cb3460a
GET /v1/drugs/c07d9485-1b8e-41fa-9e49-e1c63cb3460a?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": "25",
  "substance": "PROMETHAZINE HYDROCHLORIDE",
  "productndc": "50090-4813",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA040596",
  "marketing_category": "ANDA"
}

See everything about promethazine.

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.