CSMS #47008670
Action requiredPGA UpdateHigh urgency
Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Product Codes
CSMS #47008670 - Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Product Codes
U.S. Customs and Border Protection sent this bulletin at 04/16/2021 10:04 AM EDT
CSMS #47008670 - Food and Drug Administration (FDA) New Center for Drug Evaluation and Research (CDER) Product Codes
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:
60E[][]03/Osilodrostat Phosphate
61J[][]17/Bempedoic Acid
61T[][]37/Amisulpride
62J[][]22/Opicapone
62L[][]56/Artesunate
62Z[][]58/Avapritinib
62Z[][]59/Tazemetostat Hydrobromide
62Z[][]60/Selumetinib Sulfate
62Z[][]61/Tucatinib
62Z[][]62/Pemigatinib
62Z[][]63/Capmatinib Hydrochloride
62Z[][]64/Selpercatinib
62Z[][]65/Ripretinib
62Z[][]66/Lurbinectedin
63H[][]27/Lactitol
63O[][]11/Rimegepant Sulfate
65C[][]11/Triheptanoin
65O[][]47/Fluoroestradiol F 18
65O[][]48/Flortaucipir F 18
66W[][]05/Ozanimod Hydrochloride
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:
ACE
PGAs Affected:
FDA