United States· US:0069-0188_fb858b80-8bd4-43a6-8871-9819a35ca03f

Ibrance

A medicinal product containing palbociclib, registered in United States by Pfizer Laboratories Div Pfizer 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…normalisedIbranceATC—REGISTER NO.US:0069-0188_fb858b80…PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
palbociclib
Manufacturer
Pfizer Laboratories Div Pfizer 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 12, 2026

Packs & prices · 1

  • ndc11
    0069018821
    21 CAPSULE in 1 BOTTLE (0069-0188-21)

Regulatory notes

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

Same medicine, other countries

Palbociclib in 14 other countries

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

All palbociclib products

Authorised across Europe · EMA

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

  • Austria · Ibrammaclib
  • Bulgaria · Palbociclib
  • Denmark · Palbociclib Newbury
  • Estonia · Palbociclib
  • Finland · Palbociclib Avansor
  • United Kingdom (Northern Ireland) · Palbociclib Thornton & Ross
  • Greece · Palbociclib Faran
  • Croatia · Palbociclib
  • Hungary · Palbociclib
  • Iceland · Ibrance, Palbociclib Viatris
  • Liechtenstein · Ibrance, Palbociclib Viatris
  • Malta · Palbociclib, Palbociclib Lotus
  • Netherlands · Ibaclib, Palbociclib Elpen
  • Norway · Ibrance, Palbociclib Newbury
  • Poland · Palbociclib Polpharma
  • Sweden · Brancen, Brical

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/6b51eb0a-fad7-464e-9368-acf036d8b754
GET /v1/drugs/6b51eb0a-fad7-464e-9368-acf036d8b754?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",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "productid": "0069-0188_fb858b80-8bd4-43a6-8871-9819a35ca03f",
  "productndc": "0069-0188",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALBOCICLIB",
  "proprietary_name": "Ibrance",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207103",
  "marketing_category": "NDA",
  "nonproprietary_name": "palbociclib",
  "start_marketing_date": "20150203",
  "active_numerator_strength": "100"
}

See everything about palbociclib.

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.