Is this data not free from the government?

Yes. The source files are public and we link to them. You pay for the cleaning, the joins, the documented schema and the refresh, not for the data itself.

As Parquet or CSV files, by download link or to your own cloud bucket. The same tables load into Snowflake with the scripts we include. A Snowflake Marketplace listing is being set up and is not live yet.

Can I see the data before paying?

Yes. Ask for a sample and we send every product whose brand name starts with A, with its packages, applications and patents, plus the full data dictionary.

Does an NDC listing mean FDA approved the drug?

No. The NDC Directory also lists unapproved drugs, OTC monograph products and listings that have expired. Use the marketing category and the bridge to Drugs@FDA and the Orange Book to see which products are approved.

Does it include adverse events or label text?

No. It holds firm-level and product-level data only. There are no patient records, no FAERS or MAUDE adverse event reports and no full label text.

The NDC Directory, Orange Book, Drugs@FDA and Purple Book files are US government works in the public domain. The openFDA drug enforcement and drug shortage files are released under CC0 1.0. FDA does not endorse this product.

Available now

FDA drug data: NDC codes, Orange Book patents, Drugs@FDA approvals, recalls and shortages

The FDA NDC Directory, Orange Book, Drugs@FDA, Purple Book and openFDA recall and shortage files, typed and linked so a package code leads to its application, patents, exclusivity, recalls and shortages. 24 tables, about 1.9 million rows.

Request a sample See the full catalog

Coverage: All four NDC Directory files: about 350,000 product records and 650,000 package records, with excluded listings kept so older codes still resolve. Orange Book: about 49,000 approved products, 22,000 patent rows and 2,300 exclusivity rows. Drugs@FDA: about 29,000 applications, 52,000 products and 190,000 submissions. Purple Book: about 2,200 licensed biological products. openFDA: about 18,000 drug recall enforcement reports since 2012 and 1,600 shortage entries.

Why pay for public data

FDA publishes these as separate downloads with different keys. NDC codes appear in several segment layouts, the Orange Book and Drugs@FDA key on application number, and openFDA links only about 18 percent of recall reports to an application. This package normalizes every NDC to a nine-digit product code and an eleven-digit package code, and a bridge table links the roughly 150,000 NDC products that carry an application number to Drugs@FDA, the Orange Book and the Purple Book. About 140,000 of them match at least one.

How it is built

1
Pull the NDC Directory finished, unfinished and both excluded files, the Orange Book, Drugs@FDA, the Purple Book, and the openFDA drug enforcement and drug shortage files.
2
Type every column, keep NDC codes as text with leading zeros, build PRODUCT_NDC9 and NDC11, and flag each application number with an exact match per FDA source.
3
Blank firm names that read as a personal name, blank recall attention lines that name a person, and withhold personal emails in recall and shortage text. Rebuilt monthly from the then-current FDA files.

What is in each record

Field	Notes
PRODUCT_NDC, PRODUCT_NDC9, LABELER_CODE, NDC_FORMAT	NDC_PRODUCT: the product code as published and normalized to nine digits
PROPRIETARY_NAME, NONPROPRIETARY_NAME, DOSAGE_FORM_NAME, ROUTE_NAME	Brand and generic name, dosage form and route
MARKETING_CATEGORY_NAME, APPL_TYPE, APPL_NO, DEA_SCHEDULE	Marketing category, with the application number split into type and number
SUBSTANCE_NAME, ACTIVE_NUMERATOR_STRENGTH, ACTIVE_INGRED_UNIT, PHARM_CLASSES	Active ingredients, strengths and pharmacologic classes
NDC11, NDC11_HYPHENATED, PACKAGE_DESCRIPTION, SAMPLE_PACKAGE	NDC_PACKAGE: the eleven-digit package code built from every published layout
IN_DRUGSFDA, IN_ORANGE_BOOK, IN_PURPLE_BOOK, MATCHED_ANY	NDC_APPLICATION_BRIDGE: which FDA sources each application number matches
TE_CODE, IS_RLD, APPROVAL_DATE, MARKETING_TYPE	ORANGE_BOOK_PRODUCT: therapeutic equivalence and reference listed drug flags
PATENT_NO, PATENT_EXPIRE_DATE, PATENT_USE_CODE, EXCLUSIVITY_CODE, EXCLUSIVITY_DATE	ORANGE_BOOK_PATENT and ORANGE_BOOK_EXCLUSIVITY
SUBMISSION_TYPE, SUBMISSION_STATUS, SUBMISSION_STATUS_DATE, REVIEW_PRIORITY	DRUGSFDA_SUBMISSION: approval history for each application
LICENSE_TYPE, REF_PRODUCT_PROPER_NAME, INTERCHANGEABLE_APPROVAL_DATE, EXCLUSIVITY_EXPIRATION_DATE	PURPLE_BOOK_PRODUCT: reference products, biosimilars and interchangeables
CLASSIFICATION, REASON_FOR_RECALL, RECALL_INITIATION_DATE, RECALLING_FIRM	DRUG_RECALL_ENFORCEMENT, linked to NDC codes through DRUG_RECALL_NDC
STATUS, SHORTAGE_REASON, AVAILABILITY, PACKAGE_NDC11	DRUG_SHORTAGE: entries by company and presentation
DATA_DICTIONARY	One row for each of the 307 columns, with the FDA source field

Who uses it

Pharmacy, claims and health analytics teams
Generic and biosimilar portfolio planners
Recall, shortage and supply chain monitoring teams

Pricing

$499 a year.

No personal contact data is collected or sold in any QuestionPunk dataset.

Questions

Is this data not free from the government?: Yes. The source files are public and we link to them. You pay for the cleaning, the joins, the documented schema and the refresh, not for the data itself.
How is it delivered?: As Parquet or CSV files, by download link or to your own cloud bucket. The same tables load into Snowflake with the scripts we include. A Snowflake Marketplace listing is being set up and is not live yet.
Can I see the data before paying?: Yes. Ask for a sample and we send every product whose brand name starts with A, with its packages, applications and patents, plus the full data dictionary.
Does an NDC listing mean FDA approved the drug?: No. The NDC Directory also lists unapproved drugs, OTC monograph products and listings that have expired. Use the marketing category and the bridge to Drugs@FDA and the Orange Book to see which products are approved.
Does it include adverse events or label text?: No. It holds firm-level and product-level data only. There are no patient records, no FAERS or MAUDE adverse event reports and no full label text.
What is the license?: The NDC Directory, Orange Book, Drugs@FDA and Purple Book files are US government works in the public domain. The openFDA drug enforcement and drug shortage files are released under CC0 1.0. FDA does not endorse this product.

Tell us what you need

Geography, size and fields. A two-line email is enough, and a person replies.

Request a sample