10 digit vs 11 digit NDC code

Q.

What is the correct billing drug code for Choletec^® (Kit for Preparation of Technetium Tc 99m Mebrofenin)? We have 00270-0083-20.

A.

Yes, that is correct. The official FDA drug code is 0270-0083-20, but for reporting purposes, you add a 0 before 0270.

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INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION

Choletec^® (Kit for the Preparation of Technetium Tc 99m Mebrofenin)

Indications and Usage:
Choletec^® (Kit for Preparation of Technetium Tc 99m Mebrofenin) is a radiopharmaceutical hepatobiliary imaging agent.

IMPORTANT SAFETY INFORMATION:
Choletec (Kit for Preparation of Technetium Tc 99m Mebrofenin) is contraindicated in patients hypersensitive to mebrofenin. As is the case with the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management, and to ensure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for Choletec (Kit for Preparation of Technetium Tc 99m Mebrofenin) by clicking here.

Choletec is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831, by Jubilant HollisterStier LLC, Spokane, WA 99207.

Choletec is a registered trademark of Bracco Diagnostics Inc.