ADDYI
Active substance: flibanserin
TABLET, FILM COATED · FLIBANSERIN 100 mg/1
United StatesActive
Marketing holder: Sprout Pharmaceuticals, Inc.
Verified 2026-10-09 · openFDA NDC
- Source: openFDA NDC
- Countries with the substance registered: 1
Composition
- FLIBANSERIN · 100 mg/1
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a12093-d7cf-7bcb-a238-73389080c1bd;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 58604-214
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 58604-214 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 58604-214 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 58604-214 · Verified 2026-10-09 · open in source