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I am wondering how I may be able to access historical NDC Directory File data?

An example of the type of data I’m looking for would be for NDC Package Code 0002-3004-75, or Prozac Weekly. In the current directory files (as of 2019-06-17), the Product NDC is available as 0002-3004 within the product file, but there is no associated package file data. After looking around, I found this resource at hipaaspace.com, which lists all of the information related to this code and notes that this NDC package code is deprecated, which I suspect is why it's not in the current directory files.

I’m interested in the historical data because I’m trying to map NDC package descriptions to the NDC package codes for a trend analysis my team is performing. I took a look at the openFDA API, but it didn’t appear the package code information was available there, either.

The example query I used via the openFDA site is:

https://api.fda.gov/drug/ndc.json?search=product_ndc:"0002-3004"&limit=10

but this also shows "packaging": [].

Again, this is only provided as an example. I'm interested in obtaining the NDC Package Code for all codes in the package file that are also contained in the product file, whether the package code is deprecated or not.

2 Answers 2

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FDA Response

We don't keep the products that are discontinued in the searchable database. If you file an FOI request we can provide a dump of discontinued products from 2009 to present (this is the beginning of the electronic submissions).

where FOI = Freedom of Information

and the associated request link.

Another option

For $90 hipaaspace.com has an NDC Database dating back to 2012, with much of the same data elements.

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openFDA feeds its NDC endpoint from the FDA's National Drug Code Directory you are referring to in your question, so if information is missing from NDC then it will also be missing from openFDA.

I cannot think of any option other than submitting your question directly to the FDA.

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  • Thank you, @Denis. I did submit an inquiry to the FDA and appreciate that suggestion. When I hear back from them or if there is another option submitted I will definitely share it back.
    – Michael
    Jun 18, 2019 at 14:04

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