Glossary

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  • Patient Package Insert (PPI)

    A patient package insert contains information for patients' understanding of how to safely use a drug product.

  • Pharmaceutical Equivalents

    FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:

    • they contain the same active ingredient(s)
    • they are of the same dosage form and route of administration
    • they are identical in strength or concentration 

    Pharmaceutically equivalent drug products may differ in characteristics such as:

    • shape
    • release mechanism
    • labeling (to some extent)
    • scoring
    • excipients (including colors, flavors, preservatives) 

  • Prescription Drug Product

    A prescription drug product requires a doctor's authorization to purchase.

  • Product Number

    A product number is assigned to each drug product associated with an NDA (New Drug Application).  If a drug product is available in multiple strengths, there are multiple product numbers