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CSMS #41823060 - 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 a Center for Drug Evaluation and Research (CDER) product code listed below in 60 days. The end-date will be effective on April 27, 2020.
End-dated Code/Description
64R[][]20/Somatrem (Hormone)
64R[][]22/Somatropin (RDNA Origin) (Hormone)
64R[][]23/Somatropin, Biosynthetic (Hormone)
Please use product code 64R[][]21/Somatropin (Hormone) 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:
62G[][]64/Trifarotene (Anti-Inflammatory)
62Z[][]52/Levoleucovorin Calcium (Anti-Neoplastic - Part II)
64V[][]02/Patiromer Sorbitex Calcium (Ion-Exchange Resin)
65O[][]45/Gallium Dotatoc GA-68 (Radioactive Agent - Part II)
65O[][]46/Lutetium Lu 177 Dotatate (Radioactive Agent - Part II)
66B[][]45/Pitolisant Hydrochloride (Stimulant)
66B[][]46/Solriamfetol (Stimulant)
66N[][]11/Lurasidone Hydrochloride (Tranquilizer (Anti-Psychotic) - Part II)
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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