CSMS #41823060 - Food and Drug Administration (FDA) End-Dated and New Center for Drug Evaluation and Research (CDER) Product Codes

U.S. Customs and Border Protection sent this bulletin at 02/27/2020 12:36 PM EST

Cargo Systems Messaging Service

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.

Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Customs and Border Protection.

Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes.