Patient Package Insert (PPI)
A patient package insert contains information for patients' understanding of how to safely use a drug product.
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:
- release mechanism
- labeling (to some extent)
- excipients (including colors, flavors, preservatives)
Prescription Drug Product
A prescription drug product requires a doctor's authorization to purchase.
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