GLYCEROL PHENYLBUTYRATE - Food and Drug Administration

Set ID: f6fdd4e1-690e-487f-b950-ea9fa2ba47d1
Type: Indexing - product concept
Effective date: 2017-07-11
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Product name	Novadoz Pharmaceuticals LLC \| MSN Pharmaceuticals Inc.	2026-04-16
These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Product name	Aurobindo Pharma Limited	2026-04-09
These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Product name	Zydus Pharmaceuticals USA Inc. \| Navinta LLC \| Apothecon Pharmaceuticals Pvt Ltd	2026-04-01
These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996	Product name	Horizon Therapeutics USA, Inc.	2025-10-29
These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Product name	Par Health USA, LLC	2025-10-09
These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Product name	Lupin Pharmaceuticals, Inc.	2025-06-30
These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Product name	Teva Pharmaceuticals, Inc.	2025-03-01

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
0480-3777	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Teva Pharmaceuticals, Inc.
0480-3777-58	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Teva Pharmaceuticals, Inc.
49884-264	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Par Health USA, LLC
49884-264-95	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID . GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Par Health USA, LLC
59651-988	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Aurobindo Pharma Limited
59651-988-25	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Aurobindo Pharma Limited
70710-2193	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Zydus Pharmaceuticals USA Inc. \| Navinta LLC \| Apothecon Pharmaceuticals Pvt Ltd
70710-2193-5	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Zydus Pharmaceuticals USA Inc. \| Navinta LLC \| Apothecon Pharmaceuticals Pvt Ltd
70748-425	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Lupin Pharmaceuticals, Inc.
70748-425-01	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Lupin Pharmaceuticals, Inc.
72205-331	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Novadoz Pharmaceuticals LLC \| MSN Pharmaceuticals Inc.
72205-331-57	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Novadoz Pharmaceuticals LLC \| MSN Pharmaceuticals Inc.
72205-331-58	These highlights do not include all the information needed to use GLYCEROL PHENYLBUTYRATE ORAL LIQUID safely and effectively. See full prescribing information for GLYCEROL PHENYLBUTYRATE ORAL LIQUID. GLYCEROL PHENYLBUTYRATE oral liquid Initial U.S. Approval: 1996	Novadoz Pharmaceuticals LLC \| MSN Pharmaceuticals Inc.
75987-050	These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996	Horizon Therapeutics USA, Inc.
75987-050-06	These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996	Horizon Therapeutics USA, Inc.
75987-050-07	These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI ® (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996	Horizon Therapeutics USA, Inc.