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)
42658 HISUN PHARMACEUTICALS USA, INC. 08/05/2019 01/01/2010
14539 HERITAGE PHARMA LABS, INC. 07/29/2019 10/01/2019
72912 ADLON THERAPEUTICS L.P. 07/23/2019 10/01/2019
72237 KARYOPHARM THERAPEUTICS 07/18/2019 10/01/2019
72124 CIRCASSIA PHARMACEUTICALS INC. 07/16/2019 10/01/2019
69230 CAMBER CONSUMER CARE INC. 06/28/2019 10/01/2019
72152 SAGE THERAPEUTICS 06/26/2019 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
71894 AVEXIS INC. 06/11/2019 10/01/2019
72578 VIONA PHARMACEUTICALS INC. 06/07/2019 10/01/2019
71376 IRONSHORE PHARMACEUTICALS, INC. 06/06/2019 10/01/2019
72721 HEARTWOOD PHARMA 05/23/2019 10/01/2019

Terminated Labelers

Labeler Code Labeler Name Effective Date
61894 MARINA BIOTECH INC. 10/01/2019
69916 TRIBUTE PHARMACEUTICALS US, INC. 10/01/2019
69973 HALTON LABORATORIES 10/01/2019
13551 FSC LABORATORIES, INC. 10/01/2019
69536 FOUNDATION CONSUMER HEALTCARE, LLC 10/01/2019

Page last updated on August 12, 2019