Bile Acid [EPC] - N0000175802

Name: Table of NDC products with bile acid
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	N0000175802
Pharmacologic Name	Bile Acid
Pharmacologic Uses	bile acid
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 Bile Acid

The table contains 56 products whose active ingredient are classified under the same pharmacologic class Bile Acid [EPC].

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
0527-1326	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Lannett Company, Inc.	ACTIVE
0591-2998	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Actavis Pharma, Inc.	ACTIVE
0591-3005	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Actavis Pharma, Inc.	ACTIVE
0591-3159		Non-Proprietary Name: Ursodiol	Capsule		Actavis Pharma, Inc.	ACTIVE
0591-3159	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Actavis Pharma, Inc.	ACTIVE
0904-6890	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Major Pharmaceuticals	ACTIVE
0904-7168	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Major Pharmaceuticals	ACTIVE
24658-780	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Puracap Laboratories, Llc	ACTIVE
24658-999	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Puracap Laboratories, Llc	ACTIVE
42291-923	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Avkare	ACTIVE
42385-946	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Laurus Labs Limited	ACTIVE
42806-503	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Epic Pharma, Llc	ACTIVE
45043-001	Cholbam	Non-Proprietary Name: Cholic Acid	Capsule	Oral	Manchester Pharmaceuticals, Llc	ACTIVE
45043-002	Cholbam	Non-Proprietary Name: Cholic Acid	Capsule	Oral	Manchester Pharmaceuticals, Llc	ACTIVE
48951-4139	Ferrum Acidum Cholalicum 4 Special Order	Non-Proprietary Name: Ferrum Acidum Cholalicum 4 Special Order	Powder	Oral	Uriel Pharmacy Inc.	ACTIVE
49884-412	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Par Pharmaceutical, Inc.	ACTIVE
49884-413	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Par Pharmaceutical, Inc.	ACTIVE
50268-797	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Avpak	ACTIVE
51224-151	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Tagi Pharma, Inc.	ACTIVE
51407-754	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Golden State Medical Supply, Inc.	ACTIVE
58914-785	Urso 250	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Allergan, Inc.	ACTIVE
58914-790	Urso Forte	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Allergan, Inc.	ACTIVE
59651-421		Non-Proprietary Name: Ursodiol	Capsule		Aurobindo Pharma Limited	ACTIVE
59651-421	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Aurobindo Pharma Limited	ACTIVE
60687-100	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	American Health Packaging	ACTIVE
60687-527	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	American Health Packaging	ACTIVE
62135-430	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Chartwell Rx, Llc	ACTIVE
63629-1048	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Bryant Ranch Prepack	ACTIVE
63629-1173	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Bryant Ranch Prepack	ACTIVE
63629-2286	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Bryant Ranch Prepack	ACTIVE
63629-2287	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Bryant Ranch Prepack	ACTIVE
63629-8353	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Bryant Ranch Prepack	ACTIVE
64380-844	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Strides Pharma Science Limited	ACTIVE
64380-918	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Strides Pharma Science Limited	ACTIVE
64380-919	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Strides Pharma Science Limited	ACTIVE
64980-483	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Rising Pharmaceuticals, Inc.	ACTIVE
68001-377	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Bluepoint Laboratories	ACTIVE
68001-378	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Bluepoint Laboratories	ACTIVE
68462-473	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	ACTIVE
68462-474	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	ACTIVE
69238-1540	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Amneal Pharmaceuticals Ny Llc	ACTIVE
70710-1127	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Zydus Pharmaceuticals (usa) Inc.	ACTIVE
70710-1128	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Zydus Pharmaceuticals (usa) Inc.	ACTIVE
70710-1483	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Zydus Pharmaceuticals (usa) Inc.	ACTIVE
70771-1407	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Zydus Lifesciences Limited	ACTIVE
70771-1408	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet	Oral	Zydus Lifesciences Limited	ACTIVE
70771-1524	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Zydus Lifesciences Limited	ACTIVE
71930-015	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Eywa Pharma Inc	ACTIVE
72162-1500	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Bryant Ranch Prepack	ACTIVE
72162-1501	Ursodiol	Non-Proprietary Name: Ursodiol	Tablet, Film Coated	Oral	Bryant Ranch Prepack	ACTIVE
72664-217	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Vgyaan Pharmaceuticals Llc	ACTIVE
72789-205	Ursodiol	Non-Proprietary Name: Ursodiol	Capsule	Oral	Pd-rx Pharmaceuticals, Inc.	ACTIVE
72887-143	Ursodiol 200 Mg	Non-Proprietary Name: Ursodiol	Capsule	Oral	Fh2 Pharma Llc	ACTIVE
72887-144	Ursodiol 400 Mg	Non-Proprietary Name: Ursodiol	Capsule	Oral	Fh2 Pharma Llc	ACTIVE
79739-7143	Ursodiol 200 Mg	Non-Proprietary Name: Usodiol	Capsule	Oral	Lgm Pharma Solutions, Llc	ACTIVE
79739-7144	Ursodiol 400 Mg	Non-Proprietary Name: Usodiol	Capsule	Oral	Lgm Pharma Solutions, Llc	ACTIVE
80056-143	Reltone 200 Mg	Non-Proprietary Name: Ursodiol	Capsule	Oral	Intra-sana Laboratories	ACTIVE
80056-144	Reltone 400 Mg	Non-Proprietary Name: Ursodiol	Capsule	Oral	Intra-sana Laboratories	ACTIVE