Manufacturers 2025 billing size category list

For billing periods starting on or after Aug. 1, 2023, the manufacturer fees are based on size categories. The size categories are small, medium, and large using the count of National Drug Code (NDC) package codes for U.S. Food and Drug Administration (FDA) approved prescription drugs listed in the FDA NDC directory during the billing period for the manufacturer:

• Small size category: 10 or fewer NDCs.
• Medium size category: 11 to 39 NDCs.
• Large size category: 40 or more NDCs. 

Exception: For reporting manufacturers where all NDCs used for billing purposes on the account have an FDA market category of ANDA (approved under an abbreviated new drug application) or NDA authorized generic (approved as a new drug application for an authorized generic version of a brand name drug), or are products that are biosimilars where the proprietary and nonproprietary name are the same (approved under a BLA, biologics license application), there is no large size category. In these cases, there are two size categories: medium (40 or more NDCs) and small (39 or fewer NDCs).

Below is the list of the initial size categories to review for the 2025 billing for each registered manufacturer that was registered prior to March 1, 2025 and owes for this billing period. The size categories apply to the billing period of Jan. 1 through Dec. 31, 2024. Some accounts are responsible for multiple labeler names and those NDCs are also part of the size category for that account. Those identified as qualifying for the exception have a symbol (‡) by their name and have been placed in medium or small size categories.

Before the assessments are posted, manufacturers have 30 days to review their size category for the upcoming billing period. Manufacturers who do not agree with their size category may request a change and must complete and submit the request change to manufacturer size category form by April 15, 2025.

If in agreement with the size category, no action is needed. If a request change to manufacturer size category form is not received by April 15, 2025, the size category listed here becomes final for the 2025 billing.

See the manufacturer webpage for billing information: 
https://dfr.oregon.gov/drugtransparency/Pages/manufacturers.aspx#BillingCollections.
The initial size categories are listed below.

If in agreement with the size category, no action is needed. If a request change to manufacturer size category form is not received by Aug. 31, 2024, the size category becomes final for the 2024 billing.