United States· US:0054-0245_b04f74f8-d960-4b7a-988a-372d9a1e1406

Codeine sulfate

A codeine product containing codeine sulfate, registered in United States by Hikma Pharmaceuticals USA Inc.. The same ATC class is registered in 14 of our 19 countries.

ATC R05DA04US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about codeine sulfateAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Codeine is registered in 14 of 19 countries.

Countries holding a registration under ATC R05DA04 (codeine), 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

Search codeine products by name

Codeine · ATC R05DA04

14 / 19 countries

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

Price per daily dose

What a daily dose of codeine costs, country by country.

Normalised to the WHO defined daily dose (0.1 g), so markets compare like for like.

1 market with a comparable price for this class
Public list prices, converted to USD at the rate date shown

Open the full comparison — free account Drug prices for market access

Codeine · price per daily dose (0.1 g)

USD · FX 28 Sept 2026

CH Switzerland$1.98

Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: CODEINE SULFATE
Manufacturer: Hikma Pharmaceuticals USA Inc.
Country: United States (US)
ATC code: R05DA04
ATC class: Codeine
Defined daily dose: 0.1 g, O
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 27, 2026

Packs & prices · 2

ndc11
0054024525
100 TABLET in 1 BOTTLE (0054-0245-25)
ndc11
0054-0245-25

Regulatory notes

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

Interactions

503 interactions on record for codeine.

Graded by severity as the source publishes them — 128 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

Check codeine against other medicines How interaction checks work

Codeine · interactions on record

503 records

128 severe
371 moderate
2 minor

Most severe, free to view

TriflupromazinA04AD06severe
AlvimopanA06AH02severe
ChlorphenesinD01AE07severe
ChlorphenesinG01AX21severe

2 more interactions with mechanism and management, from a commercially licensed source.

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

Codeine in 13 other countries

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

All codeine products

Authorised across Europe · EMA

The same active substance is authorised in 16 EEA countries. Names it is sold under:

Belgium · Bronchodine, Codeïne Met Eucalyptolsmaak Conforma
Czechia · Alyostal Prick, Codein Slovakofarma
Germany · Bronchi, Codeintropfen-Ct
Denmark · Kodein, Kodein Extractumpharma
Spain · Codeisan, Toseina
France · Paderyl
United Kingdom (Northern Ireland) · Codeine Linctus Bell’s Healthcare, Codeine Phosphate
Hungary · Codinep
Ireland · Codant, Codeine Phosphate Hemihydrate Extractum Pharma
Luxembourg · Toularynx
Malta · Codeine Phosphate, Galcodine Linctus care Sugar Free
Netherlands · Codeine Phosphate Schmid Pharma, Codeïnefosfaat
Portugal · Toseína
Romania · Codeină Fosfat Lph Labormed, Codeină Fosfat Mcc
Sweden · Kodein, Kodein Extractumpharma
Slovakia · Alyostal Prick, Codein Slovakofarma

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/62e4aaa9-0e22-42cf-a6b6-410a522d6e59
GET /v1/drugs/62e4aaa9-0e22-42cf-a6b6-410a522d6e59?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": "60",
  "substance": "CODEINE SULFATE",
  "productndc": "0054-0245",
  "dosage_form": "TABLET",
  "dea_schedule": "CII",
  "strength_unit": "mg/1",
  "application_number": "NDA022402",
  "marketing_category": "NDA"
}

API reference MCP server Plans

See everything about codeine.

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.

Try it free Open in the console