CSMS# 19-000287 - FDA End-dating a CDRH Product Code and New CDER Product Codes

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06/06/2019 04:28 PM EDT

Partner Government Agencies

The Food and Drug Administration will be end-dating the CDRH Product Code listed below. The product code will be end-dated in 30 days on July 6, 2019

End-Dated Code/Description

90L—LY/ System, Radionuclide Infusion

The Food and Drug Administration has created new CDER product codes listed below. They are available immediately.

New Product Code/Description

62V—80/Tecovirimat (Anti-Viral)

62V—81/Doravirine (Anti-Viral)

62V—82/Baloxavir Marboxil (Anti-Viral)

56E—83/Eravacycline Dihydrochloride (Tetracyclines)

56E—84/Sarecycline Hydrochloride (Tetracyclines)

56E—85/Omadacycline Tosylate (Tetracyclines)

62L—55/Tafenoquine Succinate (A-Protozoal, A-Leishmanial, A-Malarial)

61M—48/Stiripentol (Anti-Convulsant)

66O—02/Avatrombopag Maleate


66O—99/Hematopoietic Agents, N.E.C

Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov