Billing for Capecitabine (Xeloda®) 500 MG Dosage Form – European Formulation Blister Pack

The manufacturer of capecitabine has notified the Food and Drug Administration (FDA) that there is a national shortage of the 500 mg. dosage form of the drug.  To accommodate this temporary shortage, the FDA has approved the sale of the European 500 mg. capecitabine formulation in the United States.  Pharmacy access to the European formulation is anticipated shortly.

Currently there is no national drug code (NDC) number assigned to the European formulation of 500 mg. capecitabine.  Until an NDC number can be assigned, suppliers are instructed to follow the instructions in the Coding Guidelines Section of the Oral Anticancer Drugs Policy Article and use the miscellaneous code J8999.  The new NDC number will be posted on the Pricing, Data Analysis, and Coding Contractor web site when it becomes available.  At that time, suppliers may use it for claim submission and discontinue use of J8999.

Refer to the Oral Anticancer Drug LCD and Policy article for additional information.