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FDA Orange Book data contains a column for strength, but it is formatted so differently from the strength columns available in other FDA data (i.e. NDC catalog). Therapeutic equivalency codes (TE codes) from Orange Book are at the dose form-route-strength level yet without a map between the strengths in Orange Book and FDA NDC catalog, I'm finding it impossible to know that a given NDC has a given TE code. The closest you could get would be to say that a given Application Number (i.e. ANDA012345) has products with 1 to n TE codes.

Mapping the strengths between the two data sources seems tedious and error prone; however, Orange Book data also contains a "Product Number" (i.e. 001, 002, 003) field that - if included at the product NDC level in other FDA NDC data sources - could be a reliable map between the two sources.

Can this be added, or is there another way to accomplish this?

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It looks to me as though you are asking about adding a data field to the FDA NDA catalog. However, you also added the tag "openfda" to your question. So I have a question for you: Are you asking about adding the field to the NDA catalog, to the openFDA data accessible via API, or both?

ZK

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  • I think the solution (for me) would be to add a field to the FDA NDC (not NDA) catalog. If it also gets added to openFDA, that's fine - I just added that as a tag b/c I got here from the openFDA site and all of those posts had that tag. Basically if you go to fda.gov/drugs/drug-approvals-and-databases/… and unzip any of the NDC Database files at the bottom and open up the product file, I would want an additional column called productnumber that would contain the application product number (i.e. 001, 002, 003, etc).
    – Joey LeGrand
    Jun 16, 2022 at 21:43
  • I'd like to forward this request to the appropriate FDA stakeholders. To do so, could you please clarify which resource you are referring to, with its exact name? Could it be this one: fda.gov/drugs/drug-approvals-and-databases/… ? Also, what method are you using to access the data? Thanks, ZK
    – Z Knight
    Jun 22, 2022 at 17:00
  • Yes - that's the resource I'm using. NDC database file - Text Version (zip format). I'm downloading the zip files that contain package and product files (either Excel or text files) and working with those.
    – Joey LeGrand
    Jul 1, 2022 at 1:25
  • Hi. You should take this question to the Electronic Drug Registration and Listing team at edrls@fda.hhs.gov. --ZK
    – Z Knight
    Jul 26, 2022 at 17:08
  • I emailed edrls who referred me to orange book who referred me to cder who I think I already emailed a while ago. This was orange book’s response. Shrug… > Thank you for your email. We acknowledge your comment. Please note that Product Numbers used in the Orange Book are for internal FDA use. If you have additional questions about how to use the NDC directory, you may email the Division of Drug Information (CDER) at druginfo@fda.hhs.gov. We are unable to map the Orange Book product numbers with the NDC directory at this time.
    – Joey LeGrand
    Jul 29, 2022 at 18:47

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