505(b)(2) Product Code

A pharmaceutical company commonly uses the FDA’s 505(b)(2) drug approval pathway when developing a product that is based on an existing approved drug but is not an exact generic equivalent. Examples include:

• A new dosage form (tablet → injection)

• A new route of administration (oral → topical)

• A new strength

• A combination of previously approved drugs

• A reformulated version with different release characteristics

• A previously approved drug used for a new indication

iKnowMed's 505(b)(2) Product Code feature reduces denials and rework across the Pharmacy, Authorization, and Billing teams by:

• Reducing reliance on free-text notes and manual reconciliation

• Improving alignment between the authorized and dispensed formulation

• Reverting financial approval if the Product Code changes after the medication is ordered​

Once enabled, a Product Code can be selected on any medication order, and is not limited to medications with a 505(b)(2) designation.