Gadolinium-based Contrast Agent [EPC] - N0000183362

Pharmacologic Code	N0000183362
Pharmacologic Name	Gadolinium-based Contrast Agent
Pharmacologic Uses	gadolinium-based contrast agent
Pharmacologic Concept	Established Pharmacologic Classes - [EPC]
Pharmacologic Concept Description	An established pharmacologic class is a term or phrase that is scientifically valid and clinically meaningful according to the following definitions: A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication. A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.

The table contains 23 products whose active ingredient are classified under the same pharmacologic class Gadolinium-based Contrast Agent [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	0270-5164	Multihance	Non-Proprietary Name: Gadobenate Dimeglumine	Injection, Solution	Intravenous	Bracco Diagnostics Inc	ACTIVE
	0270-5264	Multihance	Non-Proprietary Name: Gadobenate Dimeglumine	Injection, Solution	Intravenous	Bracco Diagnostics Inc	ACTIVE
	0407-2943	Clariscan	Non-Proprietary Name: Gadoterate Meglumine	Injection, Solution	Intravenous	Ge Healthcare	ACTIVE
	50419-320	Eovist	Non-Proprietary Name: Gadoxetate Disodium	Injection, Solution	Intravenous	Bayer Healthcare Pharmaceuticals Inc.	ACTIVE
	50419-325	Gadavist	Non-Proprietary Name: Gadobutrol	Injection	Intravenous	Bayer Healthcare Pharmaceuticals Inc.	ACTIVE
	65219-080	Gadoterate Meglumine	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-082	Gadoterate Meglumine	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-084	Gadoterate Meglumine	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-086	Gadoterate Meglumine	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-088	Gadoterate Meglumine	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-281	Gadobutrol	Non-Proprietary Name: Gadobutrol	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-287	Gadobutrol	Non-Proprietary Name: Gadobutrol	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	65219-289	Gadobutrol	Non-Proprietary Name: Gadobutrol	Injection	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
	67684-2000	Dotarem	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Guerbet Llc	ACTIVE
	67684-2001	Dotarem	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Guerbet Llc	ACTIVE
	67684-3001	Dotarem	Non-Proprietary Name: Gadoterate Meglumine	Injection	Intravenous	Guerbet Llc	ACTIVE
	70436-212	Gadobutrol	Non-Proprietary Name: Gadobutrol	Injection	Intravenous	Slate Run Pharmaceuticals, Llc	ACTIVE
	70436-214	Gadobutrol	Non-Proprietary Name: Gadobutrol	Injection	Intravenous	Slate Run Pharmaceuticals, Llc	ACTIVE