A stock bottle carries the NDC 00093-0058-01. In the 11-digit 5-4-2 format, what does the middle segment identify?

a.The specific drug product, meaning its active ingredient, strength and dosage form
b.The manufacturer or labeler that markets the product
c.The package size and type
d.The controlled substance schedule

Explanation

The three segments run labeler, product and package: the first five digits identify the company, the middle four identify the drug together with its strength and dosage form, and the last two identify the package size. So a change in strength from 10 mg to 20 mg changes the middle segment. Controlled substance schedule is not encoded anywhere in the NDC.

Law Reference: FDA

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