OHDSI Home | Forums | Wiki | Github

Mapping NDC to NDA codes

I have a dataset that contains NDC codes, and another dataset that contains NDA cods (Orange Book).

My question is how to map NDC to NDA codes.

I will be thankful to any ideas or suggestions.


interesting problem.
try https://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm

however I don’t see an NDC field there ! :frowning:

if you find the solution, please report it here.

Hi all -

Apologies if I missed this – but in reviving this year old topic, I’m wondering if there’s been a straightforward approach identified to map NDA number (as in Orange Book) to NDC code (as in the NDC product table)?

  • Jon

No progress, @jonstrong. Do you have a use case?

Building ADE reporting tools with multiple front-ends for various users / use cases, e.g., health care professionals (HCP), patients, institutions / providers. For patients, the descriptions / forms / dosing info is more “user friendly” as presented in Orange Book data, while for HCPs we have what appears to be more detailed data, keyed to NDC code (with package code appended – full 10 digits, or extended 11 digit format). We can also potentially look to a source like RxNorm, but I’m looking to see how we can build this broader view of the drug info without relying on paid license fees to commercial drug directories.

  • Jon

Understood. We use RxNorm for that structure, hierarchy and content. It’s pretty good. We map the NDC to that. NDA - we put it on the list, but without an analytical use case will probably take a while. Unless you are interested to run it through the Drug Mapping Tool.

Thx Christian. Following up a bit more on this topic. We’ve been exploring DrugBank - appears to be a solid resource (free for non-commercial ventures, can be licensed for commercial purposes). Also back to the NDC / NDA question - I need to do the homework to verify coverage and consistency between Drugs@FDA, NDC and OrangeBook for approved prescribable drugs (in the US as a start), but it would appear the “ApplNo” in the Drugs@FDA table corresponds to “appl_no” in OrangeBook, and to NDA, ANDA or BLA in the NDC product table. If this is truly the case (anyone seeing this who knows, please verify or correct me - thx!), then we can relate and do the crosswalk between NDC, OrangeBook, Drugs@FDA. I’m also becoming aware of differences between the label info in Drugs@FDA vs DailyMed – with the former being the official approved PI and label, and the latter what the Labeler may have logged, but isn’t yet necessarily approved by the FDA (If I’m understanding this correctly).

Brain swimming right about now (long day!). I really do need to immerse myself in, and become really familiar with the CDM here. The overlapping yet fragmented data across the industry is remarkable. Perhaps the drug vocabularies in the OMOP CDM would resolve this for me.

Any suggestions most welcome at this point. :slight_smile:


Maybe I’m missing something but FDA provides an export of their NDC directory. https://www.accessdata.fda.gov/cder/ndcxls.zip

You can join product.xls to package.xls and then you can use APPLICATIONNUMBER column and NDCPACKAGECODE column to get what you need. I think.