Healthcare / DOCUMENTED CSV
FDA Orange Book Product, Patent & Exclusivity Reference
Assemble drug-product research tables with FDA approval dates, therapeutic-equivalence codes, and related patent and exclusivity records. Prepared keys, code definitions and documented joins are included.
Fixed ACD source capture: October 16, 2026 · FDA coverage cutoff not stated
01 / KNOW THE FIT
A useful join starts
with a clear meaning.
What you can do with it
Add product names, ingredients, strengths and approval information to an application-coded research portfolio. Inspect related patent-use and exclusivity definitions without manually combining FDA files.
What one row means
One main-table row identifies an Orange Book application type, application number and product number. Separate tables preserve the many patent, exclusivity and therapeutic-equivalence-code relationships.
Unique keyproduct_key
How to join it
Join on product_key, such as N202155-001, or its three text components. Count or summarize patents and exclusivities separately before combining them; joining both detail tables directly multiplies rows. No NDC linkage is supplied.
Join Orange Book products, patents and exclusivities in Python →
Coverage, with the edges visible
48,865 products across 27,428 applications, including RX, OTC and DISCN categories. 2,677 products have listed patent records; 1,226 have exclusivity records. All 73,724 original bulk rows are accounted for. Exact duplicate exclusivity rows are represented with occurrence counts.
Keep in mind
- A captured analytical snapshot, not a complete approval-action history or current-stock lookup. Orange Book scope is narrower than all FDA-regulated drugs.
- Therapeutic-equivalence codes alone do not establish that two products are interchangeable. Not for medical care decisions.
- Patent and exclusivity dates are listed source values, not legal clearance or predicted generic launch dates.
- No source coverage cutoff is stated. ZIP member timestamps and capture dates are recorded separately.
Text identifiers keep leading zeros. Dates are parsed without inventing days for pre-1982 approvals. Every relationship retains its source rows; 74 exact duplicate exclusivity rows are explicitly accounted for. All used patent-use and exclusivity codes have FDA definitions. How we prepare and version our data →
02 / TRY THE SHAPE
Real rows. Before you buy.
These are the first three rows from the delivered CSV, showing 6 of 22 fields. The free download contains the first five rows and all 22 fields; it is a format sample, not a coverage test.
| product_key | trade_name | strength | approval_date | approval_date_status | patent_listing_count |
|---|---|---|---|---|---|
| A018659-001 | ALLOPURINOL | 100MG | 1986-10-24 | exact_date | 0 |
| A018659-002 | ALLOPURINOL | 300MG | 1986-10-24 | exact_date | 0 |
| A020345-001 | AMINOSYN-HF 8% | 8% (8GM/100ML) | 1996-04-04 | exact_date | 0 |
03 / NO GUESSING
Main table fields, explained.
The main table’s field dictionary from the current download. CSV has no built-in types; these are the intended import types.
| Field | Type | Meaning |
|---|---|---|
product_key | text | ACD join key: source application type + six-digit application number + hyphen + three-digit product number; e.g. N202155-001. Not an NDC. |
application_type | text | Original N (NDA) or A (ANDA); import as text. |
application_number | text | Original six-digit FDA application number; preserve leading zeros. |
product_number | text | Original three-digit product number within its application; preserve leading zeros. |
ingredient | text | Original ingredient text with only outer whitespace trimmed; combinations remain a single semicolon-separated source string. |
trade_name | text | Source trade/product name; not a unique identifier. |
dosage_form | text | Text before the single semicolon in source DF;Route; outer whitespace trimmed. |
route | text | Text after the semicolon in source DF;Route; may describe multiple routes; not exploded. |
strength | text | Source strength text; units and multi-part expressions are preserved without numeric conversion. |
applicant | text | Source abbreviated application-holder name; not a distributor or repackager. |
applicant_full_name | text | Source full application-holder name. |
te_codes | text | Original comma-separated therapeutic-equivalence codes; blank means no code supplied. Equality of codes alone does not establish interchangeability. |
approval_date | text | ISO YYYY-MM-DD only when source supplies an exact date; otherwise blank. Read approval_date_status and source_approval_date. |
approval_date_status | text | exact_date, before_1982, or missing. before_1982 means strictly earlier than 1982-01-01, not that date. |
source_approval_date | text | Original approval-date text with outer whitespace trimmed. |
reference_listed_drug | text | true/false from source Yes/No RLD flag; indicates FDA reference-listed-drug designation. |
reference_standard | text | true/false from source Yes/No RS flag; distinct from RLD. |
marketing_status | text | Source RX, OTC, or DISCN category. DISCN has several meanings and is not evidence of withdrawal for safety reasons; RX/OTC does not guarantee current availability. |
patent_listing_count | integer | Count of distinct retained patent listing rows for this product, including separate use codes and pediatric-extension entries. Not a count of unique patent numbers. |
distinct_patent_number_count | integer | Count of distinct original Patent_No strings for this product; *PED suffixes are preserved as separate source strings. |
exclusivity_record_count | integer | Count of distinct exclusivity records for this product after exact-duplicate accounting. |
source_row | text | One-based data row in retained products.txt, excluding the header. |
04 / INSIDE THE DOWNLOAD
Data, with its context.
One ZIP · 5.0 MB · 18 files. No account or subscription required.
README.mdImport guidance, method, attribution, and limitationsall_tables_dictionary.jsonField types, definitions and join guidance for all six CSV tableschecksums.jsonSHA-256 checksums for the release filescode_definitions.csvFDA definitions for the patent-use and exclusivity codes in this releasedata_dictionary.jsonTypes and definitions for every fieldexample.pyPortable Python research-portfolio join; can also be pasted into a notebookexample_input.csvFictional project labels paired with real FDA product keysexample_output.txtExpected printed output from the portable exampleexample_result.csvVerified enriched portfolio rowsexclusivities.csvDistinct exclusivity records with definitions and duplicate occurrence accountingmetadata.jsonSource provenance, production time, counts, and CSV checksumorange_book_products.csvMain prepared table · UTF-8 CSVpatents.csvRelated patent listings with code definitions, dates, flags and source-row referencesprovenance.jsonRetained source identifiers, URLs and file checksumsquality_report.jsonCoverage, missingness and product-specific quality checksrevision.jsonChanges and free-upgrade eligibility for this ACD revisionsource_row_status.csvOutcome for every original bulk source row, including accounted exact duplicatestherapeutic_equivalence.csvOne product-to-TE-code relationship per row
05 / DATES THAT MEAN SOMETHING
Sources, versions & changes.
Source versions identify the inputs. Our processing revision describes how we prepare them. Either kind of change creates a new ACD release; the package date records when it was built.
Current source versions
- Purchased source edition
- ACD capture 2026-10-16
- Primary ZIP member dates
- 2026-10-09 (file metadata; not coverage cutoff)
- FDA release / coverage cutoff
- Not stated in the retained files
- Code-definition capture
- 2026-10-16; separate FDA lookup pages
- ACD processing revision
- 1 · related tables, explicit duplicates and partial dates
- Package prepared (UTC)
- FDA Orange Book data files and field definitions
- FDA patent-use definitions
- FDA exclusivity definitions
- Orange Book preface and interpretation
Source: U.S. Food and Drug Administration. Independent preparation by Actually Clean Data; no FDA endorsement.
RELEASE HISTORY
Oct 16, 2026 · current package (UTC)
First paid ACD Orange Book release. Six related/accounting CSVs, field dictionaries, a checked Python example, checksums, and retained source/staging/preparation identities. No earlier ACD release is being compared.
Initial release: source scope and preparationProcessing corrections and improvements for your purchased source edition are free. Genuinely new source editions may be sold separately. See the update policy and access instructions.
Check the downloaded CSV’s integrity
The metadata file inside the ZIP records this SHA-256 checksum for orange_book_products.csv. A matching checksum confirms identical CSV bytes.
cf231c660a1d873eb9a07c6fc45cdd2562c25af92b76b54c5b050e5a5306e790READY TO PUT IT TO WORK?
FDA Orange Book Product, Patent & Exclusivity Reference
$29 USD · one time · 48,865 FDA application/product keys