What distinguishes an authorized generic drug from the listed drug?

• A. It is marketed under the same labeling as the listed drug
• B. It is marketed with a different labeling, packaging, product code, labeler code, or trademark than the listed drug
• C. It is a device
• D. It is only sold outside the US

Answer: (B)

An authorized generic is the same drug product as the listed drug in active ingredient, strength, dosage form, and route, but it is marketed as a generic by the brand’s own company (or an affiliate) under different labeling and branding. The defining difference is the labeling, packaging, product code, labeler code, or trademark, which distinguishes it from the listed drug even though the medicine itself is identical. This arrangement allows the brand to offer a lower-cost generic option while maintaining the same ingredients. It’s not a device, and it’s typically sold in the US, not restricted to outside markets.