Carbamoyl Phosphate Synthetase 1 Activator [EPC] - N0000184144

Name: Table of NDC products with carbamoyl phosphate synthetase 1 activator
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	N0000184144
Pharmacologic Name	Carbamoyl Phosphate Synthetase 1 Activator
Pharmacologic Uses	Carbamoyl Phosphate Synthetase 1 (CPS 1) activator
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.

NDC Products with Carbamoyl Phosphate Synthetase 1 Activator

The table contains 4 products whose active ingredient are classified under the same pharmacologic class Carbamoyl Phosphate Synthetase 1 Activator [EPC].

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
35573-459	Carglumic Acid	Non-Proprietary Name: Carglumic Acid	Tablet, For Suspension	Oral	Burel Pharmaceuticals, Llc	ACTIVE
52276-312	Carbaglu	Non-Proprietary Name: Carglumic Acid	Tablet, For Suspension	Oral	Recordati Rare Diseases	ACTIVE
68475-006	Carglumic Acid	Non-Proprietary Name: Carglumic Acid	Tablet, For Suspension	Oral	Navinta Llc	ACTIVE
71863-114	Carglumic Acid	Non-Proprietary Name: Carglumic Acid	Tablet, For Suspension	Oral	Eton Pharmaceuticals, Inc.	ACTIVE