CSMS #61683287
Action requiredPGA UpdateMedium urgency
Food and Drug Administration (FDA) New and End-Dated Center for Drug Evaluation and Research (CDER) Product Code
CSMS # 61683287 - Food and Drug Administration (FDA) New and End-Dated Center for Drug Evaluation and Research (CDER) Product Code
U.S. Customs and Border Protection sent this bulletin at 08/06/2024 04:44 PM EDT
CSMS # 61683287 - Food and Drug Administration (FDA) New and End-Dated Center for Drug Evaluation and Research (CDER) Product Code
The Food and Drug Administration (FDA) will end-date the Center for Drug Evaluation and Research (CDER) product codes listed below on September 6, 2024.
Product Code/Description
56C[][]73/Cephalexin Hydrochloride (Cephalosporins)
56E[][]21/Doxycycline Monohydrate (Tetracyclines)
60M[][]28/Naltrexone Hydrochloride (Analgesic, Narcotic)
64G[][]28/Estrogens Conjugated (Estrogen)
The Food and Drug Administration (FDA) has created new Center for Drug Evaluation and Research (CDER) product codes listed below. The product codes are available immediately.
Product Code/Description
58Q[][]06/Faricimab-svoa
61J[][]18/Inclisiran
61R[][]24/Sugammadex (Antidote)
64F[][]29/Roflumilast (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
.
Additional Information
Programs Affected:
ACEEntry Summary
PGAs Affected:
FDA