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)
72618 BIOHAVEN PHARMACEUTICALS, INC. 03/24/2020 07/01/2020
72060 INTRA-CELLULAR THERAPIES, INC. 03/19/2020 07/01/2020
71776 EYEVANCE PHARMACEUTICALS LLC 03/16/2020 07/01/2020
71881 AIMMUNE THERAPEUTICS, INC. 03/13/2020 07/01/2020
72252 NEURELIS, INC. 03/05/2020 07/01/2020
69087 CLARUS THERAPEUTICS, INC. 02/14/2020 07/01/2020
72893 ACROTECH BIOPHARMA LLC 02/04/2020 07/01/2020
72064 BLUEPRINT MEDICINES CORPORATION. 02/03/2020 07/01/2020
72611 ALMAJECT, INC. 02/02/2020 07/01/2020
72607 EPIZYME, INC. 01/30/2020 04/01/2020
72356 FOAMIX PHARMACEUTICALS INC. 01/17/2020 04/01/2020
73070 NOVO NORDISK PHARMA, INC. 01/06/2020 04/01/2020
72786 GLOBAL BLOOD THERAPEUTICS, INC. 12/27/2019 04/01/2020
72603 NORTHSTAR RX LLC 12/11/2019 04/01/2020
72647 OAKRUM PHARMA, LLC 12/06/2019 04/01/2020
72579 BEIGENE USA, INC. 12/05/2019 04/01/2020
70748 LUPIN PHARMACEUTCALS INC. 12/05/2019 04/01/2020
71863 ETON PHARMACEUTICALS, INC. 12/03/2019 04/01/2020
71351 BROOKFIELD PHARMACEUTICALS, LLC 11/25/2019 04/01/2020
70154 MONARCH PCM, LLC 11/24/2019 04/01/2020
72028 HARMONY BIOSCIENCES, LLC 11/06/2019 04/01/2020
71839 BE PHARMACEUTICALS INC. 11/05/2019 04/01/2020

Terminated Labelers

Labeler Code Labeler Name Effective Date
00258 FOREST LABORATORIES INC. 07/01/2020
62592 UCYCLYD PHARMA, INC. 07/01/2020
52118 THERAVANCE BIOPHARMA US, INC. 07/01/2020
50236 QLT OPHTHALMICS INC. 07/01/2020
71758 AVADEL SPECIALTY PHARMACEUTICALS, LLC 04/01/2020
68774 PAR PHARMACEUTICAL 04/01/2020
00066 AVENTIS PHARMACEUTICALS 04/01/2020
00316 CROWN LABORATORIES 04/01/2020
00713 COSETTE PHARMACEUTICALS 04/01/2020
60219 AMNEAL PHARMACEUTICALS 04/01/2020
61145 REPHARM LLC 04/01/2020
64253 MEDEFIL, INC. 04/01/2020
71709 METCURE PHARMACEUTICALS, INC. 04/01/2020
70408 NOSTRUM LABORATORIES, INC. 04/01/2020
51477 NESHER PHARMACEUTICALS LLC 04/01/2020
43478 ROUSES POINT PHARMACEUTICALS LLC 04/01/2020
76181 TALEC PHARMA 04/01/2020
53150 AMNEAL-AGILA, LLC 04/01/2020

Page last updated on March 26, 2020