CSMS Message: 19-000199

Title:FDA New CBER Product Codes and Synonyms
Date:2019-04-18
To:abi,acep,newace,partner
Links:previous, original, next

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.