United States· US:53345-014_3cd90bef-d64d-4fb5-97db-2cd0a72c9098

Ibuprofen

A medicinal product containing ibuprofen, registered in United States by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

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:53345-014_3cd90bef…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
IBUPROFEN
Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., 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

  • ndc11
    53345-014-01
  • ndc11
    5334501401
    1 BAG in 1 BOX (53345-014-01) / 10000 CAPSULE, LIQUID FILLED in 1 BAG

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/d9bfe5fb-e0b7-4866-b75a-dba05d5d10f6
GET /v1/drugs/d9bfe5fb-e0b7-4866-b75a-dba05d5d10f6?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": "200",
  "substance": "IBUPROFEN",
  "productndc": "53345-014",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA206568",
  "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.