CSMS# 18-000362 - FDA End-Dating CDER Product Codes and New CDER Product Codes

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05/24/2018 04:44 PM EDT

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Subject: FDA End-Dating CDER Product Codes and New CDER Product Codes



The Food and Drug Administration will be end-dating CDER product codes, listed below, in 30 days, June 24, 2018. Additionally, the Food and Drug Administration has created new CDER product codes to replace the end-dated product codes. The new additions are available immediately and are listed below.



End-Dated Product Code/Description

60L—92/ Almotriptan

New Product Code/Description

63O—02/Almotriptan Malate (Antimigraine Agent)



End-Dated Product Code/Description

60L—93/ Frova

New Product Code/Description

63O—03/ Frovatriptan Succinate (Antimigraine Agent)



End-Dated Product Code/Description

60L—86/ Naratriptan Tablets (Analgesic)

New Product Code/Description

63O—04/Naratriptan Hydrochloride (Antimigraine Agent)



End-Dated Product Code/Description

60L—87/ Rizatriptan Benzoate (Analgesic)

New Product Code/Description

63O—05/ Rizatriptan Benzoate (Antimigraine Agent)



End-Dated Product Code/Description

60L—88/ Sumatriptan (Analgesic)

New Product Code/Description

63O—06/ Sumatriptan (Antimigraine Agent)



End-Dated Product Code/Description

60L—89/ Sumatriptan Succinate (Analgesic)

New Product Code/Description

63O—07/ Sumatriptan Succinate (Antimigraine Agent)



End-Dated Product Code/Description

60L—90/ Zolmitriptan (Analgesic)

New Product Code/Description

63O—08/ Zolmitriptan (Antimigraine Agent)



End-Dated Product Code/Description

60L—91/ Zolmitritpan (Analgesic)

New Product Code/Description

63O—08/ Zolmitriptan (Antimigraine Agent)



In addition, the Food and Drug Administration has created a new CDER product code listed below, available immediately.



New Product Code/Description

63O—09/ Erenumab-aooe (Antimigraine Agent)



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