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)
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
69800 ADMA BIOLOGICS, INC. 10/31/2019 01/01/2020
72694 SERVIER PHARMACEUTICALS LLC 10/30/2019 01/01/2020
70752 QUAGEN PHARMACEUTICALS LLC 10/23/2019 01/01/2020
50261 THERAPEUCTICSMD 10/23/2019 01/01/2020
72065 XERIS PHARMACEUTICALS, INC. 10/15/2019 01/01/2020
72572 CIVICA, INC. 10/08/2019 01/01/2020
71626 MEDSTONE PHARMA LLC 09/30/2019 01/01/2020
72000 NABRIVA THERAPEUTICS US, INC. 09/23/2019 01/01/2020
72485 ARMAS PHARMACEUTICALS INC. 09/13/2019 01/01/2020
72266 FOSUN PHARMA USA 09/12/2019 01/01/2020
21922 ENCUBE ETHICALS, INC. 09/05/2019 01/01/2020
61990 APOLLO PHARMACEUTICALS USA INC. 08/19/2019 01/01/2020
42658 HISUN PHARMACEUTICALS USA, INC. 08/05/2019 01/01/2020

Terminated Labelers

Labeler Code Labeler Name Effective Date
53150 AMNEAL-AGILA, LLC 04/01/2020
66663 JAZZ PHARMACEUTICALS, INC. 01/01/2020
13310 AR SCIENTIFIC INC. 01/01/2020
53329 MEDLINE INDUSTRIES, INC. 01/01/2020
69235 MHC PHARMA, LLC 01/01/2020

Page last updated on November 25, 2019