| Title: | FDA End-dating a CDRH Product Code and New CDER Product Codes |
|---|---|
| Date: | 2019-06-06 |
| To: | abi,acep,newace,partner |
| Links: | previous, original, next |
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—03/Lusutrombopag
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