Which statement about the NDC 5-4-2 format is true?

• A. The last two digits denote the package size
• B. The first five digits denote the manufacturer
• C. The middle four digits denote the dosage form
• D. All digits sum to 11

Answer: (B)

In the 5-4-2 NDC format, the code is split into three parts: the first five digits identify the labeler or manufacturer, the middle four digits represent the product code (which covers the drug and its formulation), and the last two digits denote the package size. Therefore, the statement that the first five digits denote the manufacturer aligns with how the NDC is organized. The middle four digits do not solely indicate dosage form; they identify the specific product and its formulation, which is a broader designation. The last two digits do indicate package size, and the notion that all digits sum to 11 isn’t a feature of the NDC structure.