Gadobutrol
Active substance: gadobutrol
INJECTION · GADOBUTROL 604.72 mg/mL
United StatesActive
Marketing holder: Fresenius Kabi USA, LLC
Verified 2026-10-09 · openFDA NDC
- Source: openFDA NDC
- Countries with the substance registered: 1
Composition
- GADOBUTROL · 604.72 mg/mL
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208c-6c47-7426-a933-57974d268f3b,01a1208c-b603-73c1-be83-c6c3ff7a2b02,01a1208d-1673-74eb-9ad5-96a0aeb0fe5c,01a12090-8960-7d3f-862f-2d353a6c8f4d,01a12090-b064-78fb-bf10-17a15f86bd9c;count=16 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 65219-287
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- INTRAVENOUS
Sources
- product · openFDA NDC · 65219-287 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 65219-287 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 65219-287 · Verified 2026-10-09 · open in source