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FAQ: NDC AND DRUG LISTING

How to get NDC number

Step by step guide on how to get NDC number.  The first step to get the NDC number is the labler code application. Drug establishment registration. Manufacturing /packaging facilities must be registered with the FDA. Drug listing SPL submission How much time it will take to get the  NDC number? It will take about ten … 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

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