Services to Ease FDA Regulatory Compliance

FAQ: NDC AND DRUG LISTING

What are your fees for drug listing?

Our fees for drug listing are $250.

What are your fees for NDC assistance ?

Our fees for NDC number assistance are $199.

What information do I have to provide for Drug Listing?

For drug listing, we need the following information: Product label Labelling information Packaging configuration FEI number

How can you help me with Drug Listing?

We provide a complete service for drug listing and NDC numbers. We will support you through each stage of the process, until your registration is complete.

How much time will Drug Listing take?

Once we have the information, the process takes two to three days.

How much time does it take to obtain the NDC number?

This process takes around 48 hours.

Who needs a Drug Listing?

The owner or operator of an establishment entering into drug manufacture or preparation.

What Is the NDC Number?

The NDC number is 10 digit number, consisting of five labeller-code digits, three product digits and two of package code digits. The product code and package code can be any assigned by the manufacturer/ labeller.

What is a Drug Listing?

Drug listing is the process of providing product and labeling information to FDA in electronic format.

What is the Labeler Code?

This is the number assigned by the FDA to the manufacturer /packer/labeler of the drug.

Translate »