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)|
|72065||XERIS PHARMACEUTICALS, INC.||10/15/2019||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|
|14539||HERITAGE PHARMA LABS, INC.||07/29/2019||10/01/2019|
|72912||ADLON THERAPEUTICS L.P.||07/23/2019||10/01/2019|
|72124||CIRCASSIA PHARMACEUTICALS INC.||07/16/2019||10/01/2019|
|69230||CAMBER CONSUMER CARE INC.||06/28/2019||10/01/2019|
|70382||OCULAR THERAPEUTIX, INC.||06/20/2019||10/01/2019|
|72305||PROVELL PHARMACEUTICALS, LLC.||06/20/2019||10/01/2019|
|72606||CELLTRION USA, INC.||06/12/2019||10/01/2019|
|72578||VIONA PHARMACEUTICALS INC.||06/07/2019||10/01/2019|
|71376||IRONSHORE PHARMACEUTICALS, INC.||06/06/2019||10/01/2019|
|Labeler Code||Labeler Name||Effective Date|
|69235||MHC PHARMA, LLC||01/01/2020|
|61894||MARINA BIOTECH INC.||10/01/2019|
|69916||TRIBUTE PHARMACEUTICALS US, INC.||10/01/2019|
|13551||FSC LABORATORIES, INC.||10/01/2019|
|69536||FOUNDATION CONSUMER HEALTCARE, LLC||10/01/2019|
Page last updated on October 16, 2019