CSMS #46487539
Action requiredPGA UpdateMedium urgency
Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Product Code and End-Dated Product Code
CSMS #46487539 - Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Product Code and End-Dated Product Code
U.S. Customs and Border Protection sent this bulletin at 03/05/2021 10:32 AM EST
CSMS #46487539 - Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Product Code and End-Dated Product Code
The Food and Drug Administration (FDA) has created a new Center for Drug Evaluation and Research (CDER) Product Code listed below. The product code is available immediately.
Product Code/Description:
64R[][]25/Somapacitan-beco
Due to duplication the product code below will be end-dated in 30 days and will be end-dated on April 5, 2021.
End-Dated Code/Description
62F[][]03/Nitrofurazone
Instead, please use the product code below.
Product Code/Description
62F[][]29/Nitrofurazone
Please send any questions or concerns to the email address for the Product Code Builder Feedback:
PCBFeedback@fda.hhs.gov
For assistance with product code identification, the public may also refer to the
FDA Product Code Builder
.
Additional Information
Programs Affected:
ACEEntry Summary
PGAs Affected:
FDA