Gadobutrol

NDC 65219-287 · Fresenius Kabi USA, LLC

Generic nameGadobutrol

Dosage formINJECTION

RouteINTRAVENOUS

Active ingredient(s)GADOBUTROL

Strength604.72 mg/mL

Pharmacologic classGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

Marketing categoryANDA

Packages

65219-287-30 — 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10)

A9585 — Injection, gadobutrol, 0.1 ml Medicare Part B payment limit (ASP + 6%): $0.26

FDA lists these products with the same active ingredient.

42337-005 — gadobutrol, 42337-006 — gadobutrol, 42337-007 — gadobutrol, 50419-325 — gadobutrol, 65219-281 — Gadobutrol, 65219-289 — Gadobutrol, 70436-212 — gadobutrol, 70436-213 — gadobutrol, 70436-214 — gadobutrol, 70436-216 — gadobutrol, 70436-217 — gadobutrol, 70436-218 — gadobutrol, 70710-2064 — gadobutrol, 70710-2065 — gadobutrol, 70710-2066 — gadobutrol

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.