United States· US:58604-214_1d1d7ef0-7a05-41c3-849f-6f1778863a73

ADDYI

A flibanserin product containing flibanserin, registered in United States by Sprout Pharmaceuticals, Inc.. The same ATC class is registered in 2 of our 19 countries.

ATC G02CX02US 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…normalisedADDYIATCG02CX02REGISTER NO.US:58604-214_1d1d7ef0…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Flibanserin is registered in 2 of 19 countries.

Countries holding a registration under ATC G02CX02 (flibanserin), each read from that country’s own register.

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

Flibanserin · ATC G02CX02

2 / 19 countries

  • Canada
  • 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
FLIBANSERIN
Manufacturer
Sprout Pharmaceuticals, Inc.
Country
United States (US)
ATC code
G02CX02
ATC class
Flibanserin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    58604-214-30
  • ndc11
    5860421430
    1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Regulatory notes

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

Interactions

226 interactions on record for flibanserin.

Graded by severity as the source publishes them — 32 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

Flibanserin · interactions on record

226 records

  • 32 severe
  • 187 moderate
  • 7 minor

Most severe, free to view

  • AprepitantA04AD12severe
  • LoperamideA07DA03severe
  • EdoxabanB01AF03severe
  • BetrixabanB01AF04severe
  • 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

Flibanserin in 1 other country

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

All flibanserin products

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/e83f950a-b014-41ad-84ec-07356bea9f91
GET /v1/drugs/e83f950a-b014-41ad-84ec-07356bea9f91?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": "FLIBANSERIN",
  "productndc": "58604-214",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA022526",
  "marketing_category": "NDA"
}

See everything about flibanserin.

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.