United States· US:0904-6754_a689a700-468b-45ac-8849-371a604587f4

SudoGest 12 Hour

A pseudoephedrine product containing pseudoephedrine hydrochloride, registered in United States by Major Pharmaceuticals. The same ATC class is registered in 6 of our 19 countries.

ATC R01BA02US 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…normalisedSudoGest 12 HourATCR01BA02REGISTER NO.US:0904-6754_a689a700…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Pseudoephedrine is registered in 6 of 19 countries.

Countries holding a registration under ATC R01BA02 (pseudoephedrine), each read from that country’s own register.

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

Pseudoephedrine · ATC R01BA02

6 / 19 countries

  • Belgiumprice
  • Ireland
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Manufacturer
Major Pharmaceuticals
Country
United States (US)
ATC code
R01BA02
ATC class
Pseudoephedrine
Defined daily dose
0.24 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
    0904675415
    10 BLISTER PACK in 1 CARTON (0904-6754-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    0904-6754-15

Regulatory notes

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

Interactions

177 interactions on record for pseudoephedrine.

Graded by severity as the source publishes them — 16 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

Pseudoephedrine · interactions on record

177 records

  • 16 severe
  • 153 moderate
  • 5 minor

Most severe, free to view

  • MethylergometrineG02AB01severe
  • ErgometrineG02AB03severe
  • LinezolidJ01XX08severe
  • ProcarbazineL01XB01severe

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

Sign in to check
  • 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

Pseudoephedrine in 5 other countries

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

All pseudoephedrine products

Authorised across Europe · EMA

The same active substance is authorised in 7 EEA countries. Names it is sold under:

  • Belgium · Vasocedine
  • Estonia · Nasaxil, Sudafed
  • Spain · Pseudoefedrina Farmalider, Respidina
  • United Kingdom (Northern Ireland) · Almus Nasal And Sinus Decongestion, Care Decongestant
  • Ireland · Non-Drowsy Sudafed Decongestant
  • Luxembourg · Vasocedine Pseudoephedrine
  • Poland · Apselan, Pseudoephedrine Espefa

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/b76ae7a4-2ded-4db7-a7af-4d7e562fcb5e
GET /v1/drugs/b76ae7a4-2ded-4db7-a7af-4d7e562fcb5e?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": "120",
  "substance": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "productndc": "0904-6754",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA075153",
  "marketing_category": "ANDA"
}

See everything about pseudoephedrine.

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.