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CSMS #42090240: Food and Drug Administration (FDA) End-Dated and New Center for Drug Evaluation and Research (CDER) Product Codes


The Food and Drug Administration (FDA) will be end-dating two Center for Drug Evaluation and Research (CDER) product codes listed below in 30 days. The end-date will be effective on April 20, 2020.

End-dated Code/Description

60M[][]09/Hydromorphone HCl (Analgesic, Narcotic)
60M[][]25/Hydromorphone Hydrochloride (Analgesic, Narcotic)

Please use product code 60M[][]08, which will have an updated description of Hydromorphone Hydrochloride (Analgesic, Narcotic), instead of the end-dated codes.

The Food and Drug Administration (FDA) has added new Center for Drug Evaluation and Research (CDER) product codes listed below and are available immediately.

New Product Code/Description:

  • 62Z[][]44/Darolutamide (Anti-Neoplastic – Part II)
  • 62Z[][]45/Duvelisib (Anti-Neoplastic – Part II)
  • 62Z[][]46/Encorafenib (Anti-Neoplastic – Part II)
  • 62Z[][]47/Entrectinib (Anti-Neoplastic – Part II)
  • 62Z[][]48/Erdafitinib (Anti-Neoplastic – Part II)
  • 62Z[][]49/Fedratinib Hydrochloride (Anti-Neoplastic – Part II)
  • 62Z[][]50/Ivosidenib (Anti-Neoplastic – Part II)
  • 62Z[][]51/Levoleucovorin (Anti-Neoplastic – Part II)
  • 62Z[][]53/Alimta (Anti-Neoplastic – Part II)
  • 62Z[][]54/Pexidartinib Hydrochloride (Anti-Neoplastic – Part II)
  • 62Z[][]55/Selinexor (Anti-Neoplastic – Part II)
  • 62Z[][]56/Talazoparib Tosylate (Anti-Neoplastic – Part II)
  • 63O[][]10/Lasmiditan Succinate (Antimigraine Agent)
  • 64F[][]27/Netarsudil Dimesylate (Enzyme inhibitor)
  • 64F[][]28/Fostamatinib Disodium (Enzyme inhibitor)

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.

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