METHYLNALTREXONE BROMIDE - Food and Drug Administration

Set ID: d504bffe-70f9-e32d-e34e-5436c09079d4
Type: Indexing - Product Concept
Effective date: 2025-03-25
Version: 3
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 RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Product name	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.	2024-05-01

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
65649-150	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-150-06	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-150-60	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-150-90	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-551	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-551-02	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-551-03	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-551-07	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-552	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.
65649-552-04	These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008	Salix Pharmaceuticals, Inc. \| Patheon Manufacturing Services LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| Bausch Health Companies Inc.