PROCYSBI
Active substance: cysteamine bitartrate
GRANULE, DELAYED RELEASE · CYSTEAMINE BITARTRATE 75 mg/1
United StatesActive
Marketing holder: Horizon Therapeutics USA, Inc.
Verified 2026-10-09 · openFDA NDC
- Source: openFDA NDC
- Countries with the substance registered: 1
Composition
- CYSTEAMINE BITARTRATE · 75 mg/1
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208c-d316-7b38-9cdb-c99aa6ae6ab4,01a1208d-a351-7413-b834-3ee1c1ec8565,01a1208d-c2cd-788b-9ddc-612005403299,01a12090-b308-74f3-9b86-aeaf22a3ba67,01a12097-5aaf-70da-bbae-379c039ef95e;count=6 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 75987-140
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 75987-140 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 75987-140 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 75987-140 · Verified 2026-10-09 · open in source