New/Reinstated & Terminated Labeler Information

Notification of Potential Labeler Terminations on October 1, 2018

On March 23, 1018, 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 requires current manufacturers to sign and submit an updated NDRA on or before September 30, 2018, or, if applicable, serves as written notice of good cause to terminate an existing rebate agreement from the Medicaid Drug Rebate Program (MDRP) effective October 1, 2018.

Visit the Notification of Potential Labeler Terminations page for a list of labelers that have not yet signed an updated NDRA.

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)
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
70255 ARRAY BIOPHARMA INC. 08/01/2018 10/01/2018
76336 HRA PHARMA AMERICA INC. 08/01/2018 10/01/2018
71334 AGIOS PHARMACEUTICALS, INC. 07/31/2018 10/01/2018
71428 GLASSHOUSE PHARMACEUTICALS LLC 07/27/2018 10/01/2018
71930 EYWA PHARMA 07/24/2018 10/01/2018
69536 FOUNDATION CONSUMER HEALTHCARE, LLC 07/23/2018 10/01/2018
00990 ICU MEDICAL INC. 07/12/2018 10/01/2018
36000 BAXTER HEALTHCARE CORPORATION 06/01/2018 10/01/2018
65628 CUTISPHARMA, INC. 05/31/2018 10/01/2018
71104 BIOVERATIV US LLC 05/29/2018 10/01/2018
71332 RIGEL PHARMACEUTICALS, INC. 05/18/2018 10/01/2018
71321 BRANDYWINE PHARMACEUTICALS, LLC 05/03/2018 10/01/2018

Terminated Labelers

Labeler Code Labeler Name Effective Date
58181 NEXTSOURCE BIOTECHNOLOGY, LLC 10/01/2018
58604 SPROUT PHARMACEUTICALS, INC. 10/01/2018
69654 AYTU BIOSCIENCE, INC. 10/01/2018
24477 EKR THERAPEUTICS, INC. 10/01/2018
24486 ARISTOS PHARMACEUTICALS, INC. 10/01/2018
15310 CREEKWOOD PHARMACEUTICAL, INC 10/01/2018
69051 PROFOUNDA, INC. 10/01/2018

Page last updated on September 7, 2018