If a prescription drug has an NDC number, it must be FDA approved and can be sold. Is this statement true or false?

The statement is false. An NDC (National Drug Code) number signifies that a drug is identified and can be tracked in the marketplace, but it does not inherently confirm that the drug is FDA approved. The NDC is a unique identifier composed of three segments that represent the labeler, product, and package size. While most drugs that have NDC numbers are indeed FDA approved, there are exceptions where drugs might have an NDC but are not necessarily approved by the FDA, such as certain compounded medications or those that are considered "generally recognized as safe and effective" (GRASE) under specific formulations.

Furthermore, the presence of an NDC does not guarantee that the drug is legal or safe to sell, as it is possible for products to be assigned an NDC while still being non-compliant with FDA regulations. Therefore, just because a drug bears an NDC number does not automatically mean it is FDA approved and can be sold in the marketplace.