FDA Drug Establishment Registration and Listing Fee
Below is the fee structure for US FDA Drug Establishment Registration and Drug Listing, covering all the mandatory services to help drug (OTC, Prescription, homeopathic) manufacturers comply with FDA regulations efficiently and affordably.
We offer fast and affordable Drug Establishment Registration and Listing services. With years of experience, we help small, medium, and large manufacturers in the USA and abroad, navigate the FDA compliance process. All domestic and foreign facilities that make, repackage, or relabel drug products in the U.S. must register with the FDA.
Our Pricing
| # | Service | Fee (USD) |
|---|---|---|
| 1 | FDA Registration, NDC Labeller Code Request | $100 |
| 2 | Annual US Agent Service (Mandatory for Foreign Manufacturers) |
$650 |
| 3 | Drug Listing (Per device) | $400 |
# We offer expedited service for all customers with a processing timeline of just 14 to 18 working days
According to the U.S. FDA, OTC monograph drug facilities registered between January 1, 2024 and December 31, 2024are subject to the FY 2025 FDA facility fees as below
| # | Facility Type | FDA OMUFA Fee (USD) |
|---|---|---|
| 1 | MDF Facility (Monograph Drug Facility) | $37,556 |
| 2 | CMO Facility(Contract Manufacturing Organization) | $22,037 |
* Note: These government fees are not required upfront. The FDA typically issues invoices toward the end of the fiscal year, allowing sufficient time for preparation and payment.
| # | Service | Fee (USD) |
|---|---|---|
| 1 | Drug Label Review | $950 Per device (14 working days) |
| 2 | DMF Submission | $650 per device (30 working days) |
Frequently Asked Questions
What is FDA Drug Listing Renewal and when is it required?
FDA Drug Listing Renewal is an annual requirement for labelers to maintain active drug listings. If there are any changes to an existing drug listing, the labeler must update the listing immediately.
What if there are no changes to the drug listing?
If there are no changes, the labeller must still submit a “no change certification” during the annual renewal period (October 1st to December 31st).
What happens if a drug listing is not updated or certified during the renewal period?
If the listing is not updated or certified between October 1st and December 31st, it will be considered inactive and will be removed from the FDA database.
What must a drug establishment have to keep its FDA registration and NDC labeler code active?
A drug establishment must have at least one active drug listing to maintain its FDA drug establishment registration and NDC labeller code.
How can I get an NDC Number (Labeler Code)?
To get an NDC Labeller Code, the labeller must prepare and submit an “NDC Labeller Code Request SPL” to the FDA. The FDA does not accept paper or email submissions. The SPL must be submitted through the ESG (Electronic Submissions Gateway) or CDER Direct Portal.