Product Characteristics Have Changed Error

“If the NDC Product Code was previously submitted, then the product and generic name, source, active ingredient UNII, dosage form, active ingredient strength, product characteristics of size, shape, color and imprint code must be the same as in the most recent submission for this NDC code.”

This error was received because the newly submitted listing does not match what the FDA already has on file for the product. If you purposely change a product’s generic name, source, dosage form, etc…, you are technically creating a new product and therefore need a new NDC code. If this is a valid change such as correcting a mistake on the previous submission, then send a manual override request and a reason why the change was made to the FDA to correct.