CSMS #64764215Wednesday, April 16, 2025
PGA UpdateMedium UrgencyAction Required

CSMS # 64764215 - Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Code and New Center for Drug Evaluation and Research (CDER) and Human Foods Program (HFP) Product Codes

CSMS # 64764215 - Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Code and New Center for Drug Evaluation and Research (CDER) and Human Foods Program (HFP) Product Codes
U.S. Customs and Border Protection sent this bulletin at 04/16/2025 11:09 AM EDT
CSMS # 64764215 - Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Code and New Center for Drug Evaluation and Research (CDER) and Human Foods Program (HFP) Product Codes
The Food and Drug Administration (FDA) will be end-dating the Center for Devices and Radiological Health (CDRH) product codes listed below. The end-date will be in 30 days, on May 16, 2025.
Product Code/Description
80L[][]DH/System, Delivery, Allergen and Vaccine
The FDA has created new Center for Drug Evaluation and Research (CDER) product codes listed below. The product codes are available immediately.
Product Code/Description
60C[][]61/Mirabegron (Adrenergic)
61M[][]50/Brivaracetam (Anti-Convulsant)
61M[][]51/Pregabalin (Anti-Convulsant)
62Z[][]71/Neratinib (Anti-Neoplastic - Part II)
65C[][]12/Dextrose (Nutrient/Tonic)
The FDA has created new Human Foods Program (HFP) product codes listed below. The product codes are available immediately.
Product Code/Description
16E[][]11/Scallops (Adductor Muscle only)
16F[][]11/Scallops (Adductor Muscle only), Breaded
16G[][]11/Scallops (Adductor Muscle only), Cakes, Balls, Etc.
16O[][]11/Scallops (Adductor Muscle only), Hot Smoked, Shellfish
16T[][]11/Scallops (Adductor Muscle only), Cold Smoked, Shellfish
16X[][]54/Scallops (Adductor Muscle only), Aquaculture Harvested Fishery/Seafood Products
16Y[][]19/Shellfish Roe, Fishery Products, n.e.c.
21R[][]49/Nance, Subtropical and Tropical Fruit Purees
21S[][]49/Nance, Subtropical and Tropical Fruit
21T[][]49/Nance, Subtropical and Tropical Fruit, Dried or Paste
21U[][]49/Nance, Subtropical and Tropical Fruit, Jams, Jellies, Preserves, Marmalades, Candied, Butters, Spread
21V[][]49/Nance, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
21W[][]49/Nance, Subtropical and Tropical Fruit, Toppings or Syrups
21X[][]49/Nance, Subtropical and Tropical Fruit Pulp
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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Additional Information

Programs Affected:
ACE
PGAs Affected:
FDA