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.
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|
|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|
|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|
|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|
|49281||SANOFI PASTEUR INC||01/01/2019|
Page last updated on March 26, 2019