Cystine Depleting Agent [EPC] - N0000187051

Pharmacologic Code	N0000187051
Pharmacologic Name	Cystine Depleting Agent
Pharmacologic Uses	cystine depleting 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 8 products whose active ingredient are classified under the same pharmacologic class Cystine Depleting Agent [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	0378-9040	Cystagon	Non-Proprietary Name: Cysteamine Bitartrate	Capsule	Oral	Mylan Pharmaceuticals Inc.	ACTIVE
	0378-9045	Cystagon	Non-Proprietary Name: Cysteamine Bitartrate	Capsule	Oral	Mylan Pharmaceuticals Inc.	ACTIVE
	54482-020	Cystaran	Non-Proprietary Name: Cysteamine Hydrochloride	Solution	Ophthalmic	Leadiant Biosciences, Inc.	ACTIVE
	55292-410	Cystadrops	Non-Proprietary Name: Cysteamine Hydrochloride	Solution	Ophthalmic	Recordati Rare Diseases, Inc.	ACTIVE
	75987-100	Procysbi	Non-Proprietary Name: Cysteamine Bitartrate	Capsule, Delayed Release Pellets	Oral	Horizon Therapeutics Usa, Inc.	ACTIVE
	75987-101	Procysbi	Non-Proprietary Name: Cysteamine Bitartrate	Capsule, Delayed Release Pellets	Oral	Horizon Therapeutics Usa, Inc.	ACTIVE
	75987-140	Procysbi	Non-Proprietary Name: Cysteamine Bitartrate	Granule, Delayed Release	Oral	Horizon Therapeutics Usa, Inc.	ACTIVE
	75987-145	Procysbi	Non-Proprietary Name: Cysteamine Bitartrate	Granule, Delayed Release	Oral	Horizon Therapeutics Usa, Inc.	ACTIVE