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Gadavist

NDC 50419-325 · Bayer HealthCare Pharmaceuticals Inc.

FDA carries 3 listing records for this NDC; the most recent is shown.

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 categoryNDA

Packages

50419-325-11 2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE

50419-325-12 2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

50419-325-13 2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE

50419-325-27 5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS

50419-325-28 5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS

50419-325-29 5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS

50419-325-37 15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE

50419-325-72 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE

50419-325-75 5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS

50419-325-18 2 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS

50419-325-19 10 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS

50419-325-73 30 mL in 1 BOTTLE, GLASS (50419-325-73)

50419-325-74 65 mL in 1 BOTTLE, GLASS (50419-325-74)

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, 65219-281 — 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