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)
71403 EPI HEALTH, LLC 03/19/2019 07/01/2019
61621 ACELRX PHARMACEUTICALS, INC. 02/15/2019 07/01/2019
71981 DOMPÉ FARMACEUTICI S.P.A. 02/04/2019 07/01/2019
71715 PARATEK PHARMACEUTICALS, INC. 02/04/2019 07/01/2019
70403 ARU PHARMA INC. 02/01/2019 07/01/2019
71225 SLAYBACK PHARMA 01/31/2019 07/01/2019
69616 CATALYST PHARMACEUTICALS, INC. 01/29/2019 04/01/2019
72187 STEMLINE THERAPEUTICS, INC. 01/28/2019 04/01/2019
72495 MILLICENT U.S., INC. 01/23/2019 04/01/2019
72171 NOVIMMUNE S.A. 01/11/2019 04/01/2019
71879 EYEPOINT PHARMACEUTICALS US, INC. 01/10/2019 04/01/2019
52440 TITAN PHARMACEUTICALS, INC. 01/08/2019 04/01/2019
70505 ANALOG PHARMA, INC. 01/07/2019 04/01/2019
70114 COHERUS BIOSCIENCES, INC. 01/03/2019 04/01/2019
71571 KALA PHARMACEUTICALS, INC. 01/04/2019 04/01/2019
72626 ASEGUA THERAPEUTICS LLC 01/02/2019 04/01/2019
69932 BLUE EARTH DIAGNOSTICS 12/19/2018 04/01/2019
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

Terminated Labelers

Labeler Code Labeler Name Effective Date
16477 LASER PHARMACEUTICALS, LLC 07/01/2019
70785 IRONWOOD PHARMACEUTICALS, INC. 04/01/2019
24689 APNAR PHARMA LP 04/01/2019
71321 BRANDYWINE PHARMACEUTICALS, LLC 04/01/2019
49908 ROCHESTER PHARMACEUTICALS 04/01/2019
49281 SANOFI PASTEUR INC 01/01/2019

Page last updated on March 26, 2019