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Gadobutrol

NDC 65219-281 · 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

65219-281-02 — 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)

65219-281-07 — 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)

65219-281-10 — 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)

65219-281-15 — 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)

Billed under HCPCS

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

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

42337-005 — gadobutrol, 42337-006 — gadobutrol, 42337-007 — gadobutrol, 50419-325 — gadobutrol, 65219-287 — 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 August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.