How to get NDC number
To get the NDC number, the labeler or manufacturer must obtain a labeler code. NDC numbers are assigned to the product using the 5 digit labeler code assigned by the FDA. Step by step guide on how to get NDC number. The first step to get the NDC number is the labler code application. Drug … Continue reading How to get NDC number
FDA Drug listing requirements for API (bulk drugs)
Drug establishment registration and drug listing are mandatory requirements for APIs (bulk drugs) commercially marketed in the USA. Manufacturer of API must register their drug establishment where the product is manufactured, packed or processed and list all the drugs which are in the commercial distribution. What information is required for API drug listing ? Below … Continue reading FDA Drug listing requirements for API (bulk drugs)
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 an NDC Number? FDAbasics.com – Drug Listing
What is an NDC Number (National Drug Code) and Drug Listing? NDC number format explained. NDC number is a ten-digit numerical code assigned to drugs. The first five digits of the NDC come from the labeler code. The FDA assigns labeler code to the manufacturer, distributor, or private label distributor of the product. The first … Continue reading What Is an NDC Number? FDAbasics.com – Drug Listing
What is a Drug Listing?
Drug listing is the process of providing product and labeling information to FDA in electronic format.
What is an NDC labeler code? FDAbasics
What is an NDC labeler code, and how to get it? NDC Labeler Code is a five-digit number assigned by the FDA to firms intended to market/manufacture the drug. Labeler code constitutes the first five digits of the NDC number. After obtaining an NDC labeler code from the FDA, the firm can submit the … Continue reading What is an NDC labeler code? FDAbasics