United States· US:54348-835_eaa5cc60-19cc-a3f1-e053-2995a90a968f

Ibuprofen

A medicinal product containing ibuprofen, registered in United States by PharmPak, Inc..

US 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…normalisedIbuprofenATC—REGISTER NO.US:54348-835_eaa5cc60…PACKS LISTED14CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
IBUPROFEN
Manufacturer
PharmPak, Inc.
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 · 14

  • ndc11
    5434883500
    1 BOTTLE in 1 BOX (54348-835-00) / 1 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883508
    1 BOTTLE in 1 BOX (54348-835-08) / 8 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883510
    1 BOTTLE in 1 BOX (54348-835-10) / 10 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883512
    1 BOTTLE in 1 BOX (54348-835-12) / 12 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883520
    1 BOTTLE in 1 BOX (54348-835-20) / 20 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883530
    1 BOTTLE in 1 BOX (54348-835-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883560
    1 BOTTLE in 1 BOX (54348-835-60) / 60 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    54348-835-00
  • ndc11
    54348-835-08
  • ndc11
    54348-835-10
  • ndc11
    54348-835-12
  • ndc11
    54348-835-20
  • ndc11
    54348-835-30
  • ndc11
    54348-835-60

Regulatory notes

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

Same medicine, other countries

Ibuprofen in 16 other countries

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

All ibuprofen products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Adolorin Ibuforte Direkt, Adolorini Direkt
  • Belgium · Brufen, Brufen Forte
  • Bulgaria · Ibuprofen Nutra Essential, Ibuprofen Pharmdedict
  • Cyprus · Algovil, Algovil Rapid
  • Czechia · Brufen, Brufen Rapidcaps
  • Germany · Aktren Forte, Ambaprofen
  • Denmark · Brufen, Brufen Retard
  • Estonia · Brufen, Dolgit
  • Spain · Apirofeno, Aragel
  • Finland · Burana, Burana Mustaherukka
  • France · Advil, Advilcaps
  • United Kingdom (Northern Ireland) · 3 Months Ibuprofen Strawberry Flavour, 3 Months Plus Strawberry Flavour
  • Greece · Advil, Advil Forte
  • Croatia · Blokmax, Blokmax Forte
  • Hungary · Advil Ultra, Advil Ultra Forte
  • Ireland · Actiprofen, Advil Liquid
  • Iceland · Alvofen Express, Alvofen Junior
  • Italy · Algofen, Algopirina Febbre E Dolore Bambini Gusto Arancia Senza Zucchero
  • Liechtenstein · Ibuprofen Gen.Orph, Pedea
  • Lithuania · Brufen, Deliprom
  • Luxembourg · Brufen, Brufen Forte
  • Latvia · Brufen, Ibugard
  • Malta · Algofren, Brufen
  • Netherlands · Advil, Advil Reliva Forte Liquid Caps
  • Norway · Brufen Retard, Ibumax
  • Poland · Axoprofen, Axoprofen Forte
  • Portugal · Algik, Azevedos
  • Romania · Adagin, Adagin Forte
  • Sweden · Brufen, Brufen Retard
  • Slovenia · Brufen, Brufen Retard
  • Slovakia · Brufen, Brufen Instant

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/e0f21783-258c-4a8a-993b-20f6b1c0b547
GET /v1/drugs/e0f21783-258c-4a8a-993b-20f6b1c0b547?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": "400",
  "substance": "IBUPROFEN",
  "productndc": "54348-835",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA091625",
  "marketing_category": "ANDA"
}

See everything about ibuprofen.

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.