United States· US:71332-006_af2c2115-cb7d-4679-935a-c2200487b965

Gavreto

A pralsetinib product containing pralsetinib, registered in United States by Rigel Pharmaceuticals, Inc.. The same ATC class is registered in 8 of our 19 countries.

ATC L01EX23US 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…normalisedGavretoATCL01EX23REGISTER NO.US:71332-006_af2c2115…PACKS LISTED6CHECKEDSeptember 27, 2026

Where it is registered

Pralsetinib is registered in 8 of 19 countries.

Countries holding a registration under ATC L01EX23 (pralsetinib), each read from that country’s own register.

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

Pralsetinib · ATC L01EX23

8 / 19 countries

  • Belgiumprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Norwayprice
  • Polandprice
  • 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
PRALSETINIB
Manufacturer
Rigel Pharmaceuticals, Inc.
Country
United States (US)
ATC code
L01EX23
ATC class
Pralsetinib
Defined daily dose
0.4 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 6

  • ndc11
    7133200612
    120 CAPSULE in 1 BOTTLE (71332-006-12)
  • ndc11
    7133200660
    60 CAPSULE in 1 BOTTLE (71332-006-60)
  • ndc11
    7133200690
    90 CAPSULE in 1 BOTTLE (71332-006-90)
  • ndc11
    71332-006-12
  • ndc11
    71332-006-60
  • ndc11
    71332-006-90

Regulatory notes

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

Interactions

93 interactions on record for pralsetinib.

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

Pralsetinib · interactions on record

93 records

  • 16 severe
  • 77 moderate

Most severe, free to view

  • KetoconazoleH02CA03severe
  • ClarithromycinJ01FA09severe
  • KetoconazoleJ02AB02severe
  • Darunavir and cobicistatJ05AR14severe
  • 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.

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/8af0595f-7d73-415f-8223-228696f98457
GET /v1/drugs/8af0595f-7d73-415f-8223-228696f98457?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": "100",
  "substance": "PRALSETINIB",
  "productndc": "71332-006",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA213721",
  "marketing_category": "NDA"
}

See everything about pralsetinib.

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.