New/Reinstated & Terminated Labeler Information

Notification of Labeler Terminations on October 1, 2018

On March 23, 2018, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final notice for the updated Medicaid National Drug Rebate Agreement (NDRA) CMS-2397-FN (Final Notice) that announced changes to the NDRA (83 Fed. Reg. 12770).

The Final Notice required current manufacturers to sign and submit an updated NDRA on or before the compliance deadline of September 30, 2018, or their labeler code(s) would be terminated from the Medicaid Drug Rebate Program (MDRP) effective October 1, 2018.

Visit the Final Notification of Labeler Terminations page for a list of labelers that did not submit an updated NDRA before the compliance deadline and, therefore, were terminated from the MDRP effective October 1, 2018.

New/Reinstated Labelers

The information below identifies new/reinstated and terminated labelers.  This page will be updated as new information is available so please check back often.

For definitions of optional and mandatory effective dates, please see the Medicaid Drug Rebate Program page.

Labeler Code Labeler Name Optional Effective Date (for State Coverage) Mandatory Effective Date (for State Coverage)
71858 IBSA PHARMA, INC. 12/12/2018 04/01/2019
71777 LOXO ONCOLOGY, INC. 12/12/2018 04/01/2019
10094 AQUESTIVE THERAPEUTICS, INC. 12/05/2018 04/01/2019
46017 MYLAN CONSUMER HEALTHCARE, INC. 11/09/2018 04/01/2019
61145 REPHARM LLC 11/05/2018 04/01/2019
72126 AKCEA THERAPUETICS, INC. 10/31/2018 01/01/2019
69292 AMICI PHARMACEUTICALS LLC 10/30/2018 01/01/2019
71258 PROGENICS PHARMACEUTICALS, INC. 10/29/2018 01/01/2019
71779 VERASTEM, INC. 10/25/2018 01/01/2019
71558 INSMED INCORPORATED 10/24/2018 01/01/2019
72511 AMGEN USA INC. 10/22/2018 01/01/2019
71773 TETRAPHASE PHARMACEUTICALS, INC. 10/22/2018 01/01/2019
71717 MEGALITH PHARMACEUTICALS INC. 10/17/2018 01/01/2019
70594 XELLIA PHARMACEUTICALS USA, LLC 10/17/2018 01/01/2019
70127 GREENWICH BIOSCIENCES, INC. 10/14/2018 01/01/2019
24689 APNAR PHARMA LP 10/08/2018 01/01/2019
72245 FORTE BIO-PHARMA LLC 10/11/2018 01/01/2019
70726 ITF PHARMA, INC. 10/11/2018 01/01/2019
50228 SCIEGEN PHARMACEUTICALS, INC. 10/11/2018 01/01/2019
70428 DERMIRA, INC. 10/04/2018 01/01/2019
72205 NOVADOZ PHARMACEUTICALS, LLC 10/03/2018 01/01/2019
00254 PAR PHARMACEUTICAL, INC. 09/28/2018 01/01/2019
42192 ACELLA PHARMACEUTICALS, LLC 09/28/2018 01/01/2019
70677 MCKESSON CORPORATION 09/24/2018 01/01/2019
52856 PTC THERAPEUTICS, INC. 09/20/2018 01/01/2019
16781 ONSET DERMATOLOGICS LLC 09/12/2018 01/01/2019
10148 COTHERIX, INC. 09/06/2018 01/01/2019
71904 AMICUS THERAPEUTICS, INC. 09/06/2018 01/01/2019
71336 ALNYLAM PHARMACEUTICALS, INC. 09/05/2018 01/01/2019
69557 SCILEX PHARMACEUTICALS 08/29/2018 01/01/2019
71369 AKARX, INC. 08/27/2018 01/01/2019
71045 ACHAOGEN, INC. 08/17/2018 01/01/2019
70010 GRANULES PHARMACEUTICALS, INC. 08/15/2018 01/01/2019
70621 BIOFRONTERA INC. 08/06/2018 01/01/2019

Terminated Labelers

There currently are no labeler terminations for April 1, 2019.

Page last updated on December 13, 2018