How to get NDC number

Step by step guide on how to get NDC number. 

  1. The first step to get the NDC number is the labler code application.
  2. Drug establishment registration.
  3. Manufacturing /packaging facilities must be registered with the FDA.
  4. Drug listing SPL submission

how to get ndc number

How much time it will take to get the  NDC number?

It will take about ten business days to obtain a labeler code. After labeler code approval within 2 to 3 business days, the drug listing process can be completed.

What information is required for NDC drug listing?

  • Proprietary name
  • Name of active ingredients and concentration
  • Name of inactive ingredients
  • Labeler DUNS number
  • Manufacturer’s DUNS number
  • Marketing category
  • Packaging configuration
  • Product characteristics  (color, size, and scoring )
  • Marketing start date
  • Labeling information ( Indication, Dosage, Warnings, etc..)
  • Product label  design

How much is the FDA fee for NDC  drug listing?

FDA does not charge a fee for an NDC drug listing.

Here is our fee structure for NDC drug listing assistance.

Labeler code application  $ 399 one time fee

Drug establishment registration $ 299

Drug listing $ 299 ( fee may vary based on the  product type)

Foreign facilities are required to appoint US Agent for labeler code application and drug establishment registration purpose/

FDAbasics can answer all your questions on How to Get  NDC number and assist you in complying with FDA drug listing requirements quickly.  We offer complete assistance for NDC drug listing, labeler code application, and drug establishment registration.  There is no hidden fee.

If you have any questions or need assistance for the NDC drug listing or NDC labeler code application, contact us. 

You can find more information about NDC number format at the below link.

 

NDC Number

If your product is detained at the port of entry due to noncompliance with FDA registration and listing requirements, FDAbasics  shall offer quick assistance to comply with FDA requirements.

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