index.md

Programmatic access and formatting of U.S Food And Drug Administration (FDA) Orange Book data

The FDA provides public access to the list of approved drug products (i.e. the Orange Book).

FDA Information on Drugs.
For some reasons, that list can be retrieved from two distinct resources: https://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip and https://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM527389.zip

The archive features three data files, i.e. exclusivity.txt patent.txt products.txt

As of March 2019, the products.txt table contains 36,771 entries, with the following list of attributes:
Ingredient
DF;Route
Trade_Name
Applicant
Strength
Appl_Type
Appl_No
Product_No
TE_Code
Approval_Date
RLD
RS
Type
Applicant_Full_Name

Detail descriptions of these variables are posted at https://www.fda.gov/drugs/informationondrugs/ucm129689.htm#descriptions

The Appl_Type attribute features two mutually exclusive values: "A" or "N".
"N" stands for New Drug Applications while "N" refers to generic (aka ANDA for Abbreviated New Drug Applications).

References
PubChem Substance and Compound databases Nucleic Acids Research, Vol. 44, Issue D1, 04 January 2016.
PUG-SOAP and PUG-REST: web services for programmatic access to chemical information in PubChem Nucleic Acids Research, 2015, Vol. 43, Web Server issue W605–W611.
Structured Product Labeling Guidance for Industry: Indexing Structured Product Labeling.