CSMS# 15-000464 - FDA Addition of a New Product Class and Termination of a Prod Code for CDER Products
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FDA Addition of a New Product Class & End-Date of a Product Code for Center for Drug Evaluation and Research(CDER)Products
The Food And Drug Administration has added a new Product Class Code - L – Phosphate Binder to Industry 63 - Human/Animal Drugs. This new Class Code will be available 7/22/15. The following products have been added under this Class:
Product Code Product Description
63L[][]01 Ferric Citrate (Phosphate Binder)
63L[][]02 Lanthanum Carbonate (Phosphate Binder)
63L[][]03 Sevelamer Carbonate (Phosphate Binder)
63L[][]04 Sevelamer Hydrochloride (Phosphate Binder)
63L[][]05 Sucroferric Oxyhydroxide (Phosphate Binder)
The Food And Drug Administration will be deleting the Center for Drug Evaluation and Research product code below. This product code will be deleted effective 08/22/2015, and the use of this code after that date will result in a data transmission error.
63A[][]08 Sevelamer HCL (Bone Calcium Regulator)
This deleted code is replaced by the new code 63L[][]04 Sevelamer Hydrochloride (Phosphate Binder).
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov.
FDA Addition of a New Product Class & End-Date of a Product Code for Center for Drug Evaluation and Research(CDER)Products
The Food And Drug Administration has added a new Product Class Code - L – Phosphate Binder to Industry 63 - Human/Animal Drugs. This new Class Code will be available 7/22/15. The following products have been added under this Class:
Product Code Product Description
63L[][]01 Ferric Citrate (Phosphate Binder)
63L[][]02 Lanthanum Carbonate (Phosphate Binder)
63L[][]03 Sevelamer Carbonate (Phosphate Binder)
63L[][]04 Sevelamer Hydrochloride (Phosphate Binder)
63L[][]05 Sucroferric Oxyhydroxide (Phosphate Binder)
The Food And Drug Administration will be deleting the Center for Drug Evaluation and Research product code below. This product code will be deleted effective 08/22/2015, and the use of this code after that date will result in a data transmission error.
63A[][]08 Sevelamer HCL (Bone Calcium Regulator)
This deleted code is replaced by the new code 63L[][]04 Sevelamer Hydrochloride (Phosphate Binder).
Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov.
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