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)
71376 IRONSHORE PHARMACEUTICALS, INC. 06/06/2019 10/01/2019
72721 HEARTWOOD PHARMA 05/23/2019 10/01/2019
72508 NEOPHARMA INC. 04/25/2019 07/01/2019
69853 PORTOLA PHARMACEUTICALS, INC. 04/19/2019 07/01/2019
68418 BIOCODEX, INC. 04/17/2019 07/01/2019
72733 SANOFI US CORPORATION 04/05/2019 07/01/2019
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

Terminated Labelers

Labeler Code Labeler Name Effective Date

Page last updated on June 7, 2019