What is NDC number?
National Drug Code or NDC is a 10-digit identification number assigned to each drug product in the US market (either OTC or prescription). The NDC number is primarily used for medical billing and insurance purposes, it also can be presented a proof of proper FDA drug listing.
The first 5 digits of NDC code, known as labeler code, will be assigned by the FDA to the brand owner, packer and/or the manufacturer of the drug. The second 5 digits will be generated by labeler company according to the drug formulation and the packaging data.
How to obtain the Labeler Code?
To obtain the Labeler code, the labeler firm must submit a request in SPL format (Structured Product Labeling) via FDA specific portals ESG or CDER Direct. The labeler code request cannot be submitted by email in a paper format. To successfully submit the labeler code application, the applicant must have the firm’s DUNS number and the DUNS record must precisely match the labeler code application data. Below are the steps normally involved in labeler code application process.
1- FDA Labeler code application submission
2- Response to possible FDA questions
3- Labeler code assignment
4- Labeler code activation
The labeler code assignment can take up to 10 days. The FDA may contact the applicant for verification purposes. The labeler code application may be rejected by the FDA if the information is not properly submitted or if the applicant cannot provide satisfying answers to FDA questions. If the applicant is a foreign entity, it is mandatory to appoint a US agent for FDA communication purposes.
FDA Listing Inc can help your firm with labeler code application and can act as US agent to facilitate the FDA communications. Please contact us by phone +1 929 376 7870 or email us at info@fdalisting.com
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