CSMS# 19-000199 - FDA New CBER Product Codes and Synonyms

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04/18/2019 11:45 AM EDT

Partner Government Agencies

The Food and Drug Administration has added new CBER product codes and synonyms under Industry Code 57. The new product codes, descriptions, and new synonyms are listed below. The new codes and synonyms are available immediately.



New Product Code/Description



57H--01/Cholera Vaccine

57I--20/DTaP & Polio & Haemophilus b & Hepatitis B Vaccine

57U--45/Coagulation Factor Xa

57V—21/Zika Virus

57V--22/Babesia microti



Product Code/Description/Synonym



57M—01/Hematopoietic Progenitor Cells (HPC), Cord Blood/Umbilical Cord Blood Stem Cells

57M--02/Hematopoietic Progenitor Cells (HPC), Apheresis/Peripheral Blood Stem Cells

57M—03/Peripheral Blood Mononuclear Cells/Lymphocytes (Donor Lymphocytes for Infusion, T Cells)



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