Reads openFDA's bulk download files for Drugs@FDA (drug/drugsfda)
and the NDC directory (drug/ndc) and returns a dvobject with
one table per record level, field names as in the files.
Usage
parseOpenFDA(
drugsfda_path = NULL,
ndc_path = NULL,
release = NULL,
release_date = NULL,
retrieved_at = NULL
)Arguments
- drugsfda_path
Character or NULL. Path to the Drugs@FDA download (zip or JSON).
- ndc_path
Character or NULL. Path to the NDC directory download (zip or JSON).
- release
Character or NULL. Release label, e.g.
"2026-10".- release_date
Date,
"YYYY-MM-DD"or NULL. Release date; by default the files' export date.- retrieved_at
Date,
"YYYY-MM-DD"or NULL. Date the files were downloaded.
Value
A dvobject with tibbles. From Drugs@FDA:
drugsfda_application (key application_number),
drugsfda_product (key application and product_number),
drugsfda_active_ingredient, drugsfda_submission (key
application, submission_type and submission_number),
drugsfda_submission_property_type,
drugsfda_application_doc and drugsfda_openfda. From the
NDC directory: ndc_product (key product_id),
ndc_active_ingredient, ndc_route, ndc_pharm_class,
ndc_packaging and ndc_openfda. Only the tables of the
files given are built.
Details
Each download is one JSON object, {meta, results}, usually zipped
(drug-drugsfda-0001-of-0001.json.zip,
drug-ndc-0001-of-0001.json.zip). Zips are read directly, without
extracting them to disk; an unzipped .json file works too. The
parser checks the number of records against meta.results.total.
Drugs@FDA lists FDA application products (NDA, ANDA, BLA); the NDC
directory lists products registered for sale, including products sold
under an OTC monograph without an application. Every application, product,
submission and listing is kept as the files have it, including tentative
approvals (submission_status "TA"); the parser does no status
grouping and no matching across sources.
YYYYMMDD dates become dates. NDC packaging dates are written two ways
(20220525 and 04-DEC-09) and are kept as text, as written.
finished and sample are logical. Every other field stays text.
The openfda block of each record is kept as (key, field, value)
rows; it is openFDA's annotation, and it can belong to another drug (for
example ANDA202111).
release_date defaults to the files' meta.last_updated (the
export date) when every file given has the same one.
Parsing the full Drugs@FDA and NDC files takes about a minute and needs roughly 300 MB of memory.
openFDA data are released under CC0 1.0. openFDA asks for credit, which is
recorded in the object's metadata (see get_source_metadata),
and states: "Do not rely on openFDA to make decisions regarding medical
care."
Examples
openfda_dir <- system.file("extdata", "openfda", package = "dbparser")
openfda <- parseOpenFDA(
drugsfda_path = file.path(openfda_dir,
"drug-drugsfda-0001-of-0001.json.zip"),
ndc_path = file.path(openfda_dir, "drug-ndc-0001-of-0001.json.zip"),
release = "2026-10")
#> Parsing openFDA Drugs@FDA...
#> Parsing openFDA NDC directory...
#> Parsed 9 Drugs@FDA applications and 9 NDC listings.
openfda$drugsfda_product[, c("application_number", "brand_name",
"marketing_status")]
#> # A tibble: 21 × 3
#> application_number brand_name marketing_status
#> <chr> <chr> <chr>
#> 1 ANDA076219 MIRTAZAPINE Prescription
#> 2 ANDA076219 MIRTAZAPINE Prescription
#> 3 ANDA076219 MIRTAZAPINE Prescription
#> 4 ANDA076220 OFLOXACIN Discontinued
#> 5 ANDA076220 OFLOXACIN Discontinued
#> 6 ANDA076220 OFLOXACIN Discontinued
#> 7 NDA007245 AEROLONE Discontinued
#> 8 ANDA085638 CODEINE, ASPIRIN, APAP FORMULA NO. 4 Discontinued
#> 9 BLA018780 HUMULIN R PEN Over-the-counter
#> 10 BLA018780 HUMULIN R Over-the-counter
#> # ℹ 11 more rows
get_source_metadata(openfda)
#> # A tibble: 1 × 12
#> metadata_version source source_name release release_date retrieved_at
#> <chr> <chr> <chr> <chr> <date> <date>
#> 1 1 openfda openFDA (U.S. Food… 2026-10 2026-10-20 NA
#> # ℹ 6 more variables: source_url <chr>, licence <chr>, licence_url <chr>,
#> # attribution <chr>, files <list>, parser <chr>