Order Entry & ProcessingQuestion 98 of 100

A product carries the 11-digit NDC 00093-3109-56. What does the middle four-digit segment identify?

a.The specific drug, its strength, and its dosage form
b.The labeler, meaning the manufacturer or distributor
c.The package size and package type
d.The lot number assigned during manufacturing

Explanation

An 11-digit NDC is written in a 5-4-2 format: the first segment is the labeler code, the middle four digits are the product code (drug, strength, and dosage form), and the last two digits are the package code. The lot number is a separate manufacturing identifier and is never part of the NDC.

Law Reference: FDA

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