Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998.

🧬 openFDA Drug Labeling – JSON Dataset

This dataset contains structured drug labeling information (FDA labels) provided by DailyMed and made available through the openFDA Drug Labeling endpoint.

The dataset includes 13 compressed .zip files with drug label records in JSON format. Each record reflects the full label submitted to the FDA, and the structure matches what you would receive from the /drug/label API.

📁 Dataset Contents

• 13 ZIP files
• Each file contains multiple JSON documents representing FDA-approved drug labels
• Data fields include (but are not limited to):
  • drug_interactions
  • warnings
  • indications_and_usage
  • contraindications
  • adverse_reactions
  • dosage_and_administration
  • brand_name, generic_name
  • ...and many others

You will also find the 'Human Drug.xlsx' file included in the dataset, which contains the complete data dictionary for reference.

🔄 Updates

This dataset reflects the most recent version available as of April 9, 2025. According to the source, previous records may be modified in future updates. For accuracy and completeness, all files should be downloaded together.

📚 Sources and More Information

• openFDA Drug Labeling Downloads
• API Documentation
• DailyMed Main Site

⚠️ Disclaimer (Please Read Carefully)

Do not rely on openFDA to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of FDA-regulated products. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

Full terms available here: openFDA Terms of Service

🛠️ Notes for Usage

This dataset is ideal for applications involving: - Drug safety analysis - Drug interaction monitoring - Medical language modeling - Retrieval-augmented generation (RAG) agents - Regulatory and pharmacovigilance systems

You may want to extract and preprocess only relevant fields before vectorizing or feeding them into an AI model for efficiency and performance.

This dataset provides data for new prescription drugs introduced to market in California with a Wholesale Acquisition Cost (WAC) that exceeds the Medicare Part D specialty drug cost threshold. Prescription drug manufacturers submit information to HCAI within a specified time period after a drug is introduced to market. Key data elements include the National Drug Code (NDC) administered by the FDA, a narrative description of marketing and pricing plans, and WAC, among other information. Manufacturers may withhold information that is not in the public domain. Note that prescription drug manufacturers are able to submit new drug reports for a prior quarter at any time. Therefore, the data set may include additional new drug report(s) from previous quarter(s).

There are two types of New Drug data sets: Monthly and Annual. The Monthly data sets include the data in completed reports submitted by manufacturers for calendar year 2025, as of July 8, 2025. The Annual data sets include data in completed reports submitted by manufacturers for the specified year. The data sets may include reports that do not meet the specified minimum thresholds for reporting.

The program regulations are available here: https://hcai.ca.gov/wp-content/uploads/2024/03/CTRx-Regulations-Text.pdf

The data format and file specifications are available here: https://hcai.ca.gov/wp-content/uploads/2024/03/Format-and-File-Specifications-version-2.0-ada.pdf

DATA NOTES: Due to recent changes in Excel capabilities, it is not recommended that you save these files to .csv format. If you do, when importing back into Excel the leading zeros in the NDC number column will be dropped. If you need to save it into a different format other than .xlsx it must be .txt

This dataset contains text file snapshots from the National Drug Code Directory during the years 2000-2018, as available in the Internet Archive (web.archive.org) on April 11, 2018. The files span several database and formatting changes, but together they provide a more comprehensive list of National Drug Codes than are available in the most recent database snapshot (https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm).

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.

The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. � 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

The PATH Study was launched in 2011 to inform the Food and Drug Administration's regulatory activities under the Family Smoking Prevention and Tobacco Control Act (TCA). The PATH Study is a collaboration between the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), and the Center for Tobacco Products (CTP), Food and Drug Administration (FDA). The study sampled over 150,000 mailing addresses across the United States to create a national sample of people who use or do not use tobacco. 45,971 adults and youth constitute the first (baseline) wave, Wave 1, of data collected by this longitudinal cohort study. These 45,971 adults and youth along with 7,207 "shadow youth" (youth ages 9 to 11 sampled at Wave 1) make up the 53,178 participants that constitute the Wave 1 Cohort. Respondents are asked to complete an interview at each follow-up wave. Youth who turn 18 by the current wave of data collection are considered "aged-up adults" and are invited to complete the Adult Interview. Additionally, "shadow youth" are considered "aged-up youth" upon turning 12 years old, when they are asked to complete an interview after parental consent. At Wave 4, a probability sample of 14,098 adults, youth, and shadow youth ages 10 to 11 was selected from the civilian, noninstitutionalized population (CNP) at the time of Wave 4. This sample was recruited from residential addresses not selected for Wave 1 in the same sampled Primary Sampling Unit (PSU)s and segments using similar within-household sampling procedures. This "replenishment sample" was combined for estimation and analysis purposes with Wave 4 adult and youth respondents from the Wave 1 Cohort who were in the CNP at the time of Wave 4. This combined set of Wave 4 participants, 52,731 participants in total, forms the Wave 4 Cohort. At Wave 7, a probability sample of 14,863 adults, youth, and shadow youth ages 9 to 11 was selected from the CNP at the time of Wave 7. This sample was recruited from residential addresses not selected for Wave 1 or Wave 4 in the same sampled PSUs and segments using similar within-household sampling procedures. This "second replenishment sample" was combined for estimation and analysis purposes with the Wave 7 adult and youth respondents from the Wave 4 Cohorts who were at least age 15 and in the CNP at the time of Wave 7. This combined set of Wave 7 participants, 46,169 participants in total, forms the Wave 7 Cohort. Please refer to the Restricted-Use Files User Guide that provides further details about children designated as "shadow youth" and the formation of the Wave 1, Wave 4, and Wave 7 Cohorts. Dataset 0002 (DS0002) contains the data from the State Design Data. This file contains 7 variables and 82,139 cases. The state identifier in the State Design file reflects the participant's state of residence at the time of selection and recruitment for the PATH Study. Dataset 1011 (DS1011) contains the data from the Wave 1 Adult Questionnaire. This data file contains 2,021 variables and 32,320 cases. Each of the cases represents a single, completed interview. Dataset 1012 (DS1012) contains the data from the Wave 1 Youth and Parent Questionnaire. This file contains 1,431 variables and 13,651 cases. Dataset 1411 (DS1411) contains the Wave 1 State Identifier data for Adults and has 5 variables and 32,320 cases. Dataset 1412 (DS1412) contains the Wave 1 State Identifier data for Youth (and Parents) and has 5 variables and 13,651 cases. The same 5 variables are in each State Identifier dataset, including PERSONID for linking the State Identifier to the questionnaire and biomarker data and 3 variables designating the state (state Federal Information Processing System (FIPS), state abbreviation, and full name of the state). The State Identifier values in these datasets represent participants' state of residence at the time of Wave 1, which is also their state of residence at the time of recruitment. Dataset 1611 (DS1611) contains the Tobacco Universal Product Code (UPC) data from Wave 1. This data file contains 32 variables and 8,601 cases. This file contains UPC values on the packages of tobacco products used or in the possession of adult respondents at the time of Wave 1. The UPC values can be used to identify and validate the specific products used by respondents and augment the analyses of the characteristics of tobacco products used

The Monthly Prescription Drug Plan Formulary and Pharmacy Network Information files contain formulary and pharmacy network data for Medicare Prescription Drug Plans and Medicare Advantage (MA) Prescription Drug Plans (with the exception of employer and Program of All-Inclusive Care for the Elderly plans). Notice: CMS has identified an issue that resulted in a 15% coinsurance for plans with Defined Standard benefits to be listed rather than a 25% coinsurance in the Beneficiary Cost File under certain scenarios. This issue affected the October 2023 to November 2024 data. CMS will re-post the corrected data in batches between now and May 2025. The following files have already been corrected and re-posted: October 2024 November 2024 These non-identifiable files are available on a monthly basis and are comprised of the following tables: Plan Information - Information such as plan name, contract ID, plan ID, service area, and plan type. Geographic Locator - MA and Prescription Drug Plans region codes and county codes. Basic Drugs Formulary - Formulary details for each plan including National Drug Codes (NDCs), cost share tier level, and indicators for step therapy, quantity limits, and prior authorization. Excluded Drugs Formulary - Enhanced alternative plans may elect to provide a supplemental benefit and cover excluded drugs. File includes formulary details for excluded drugs that are covered by the plan (for enhanced alternative plans only). Beneficiary Cost - Plan level cost sharing details for preferred, non-preferred, and mail order network pharmacies. Pharmacy Network - National Provider Identifier (NPI) numbers for each network pharmacy including preferred, retail, and mail order indicators. Indication Based Coverage Formulary File - Includes drugs covered based on FDA-approved indication for each plan. Insulin Beneficiary Cost File - Plan level cost sharing details for insulin at preferred, non-preferred and mail order network pharmacies. These are large files and can take time to download. Please read the “Agreement for Use” in the Resources section below. This document contains important information regarding timeframes for obtaining data as well as data accuracy and integrity. The Quarterly Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information is also available to access for the quarterly level information. Please note: The Part D benefit year information for plans become available in October of the year prior. For example, year 2024 data is available in the October, November and December 2023 monthly files. Year 2024 data continues to be available in the January through September 2024 monthly files, then beginning in October of 2024 year 2025 data becomes available. Estimated release dates for upcoming 2025 monthly data (files reflect data for the month in which the file is released): 2/26/25 3/26/25 4/23/25 5/21/25 6/18/25 7/30/25 8/27/25 9/24/25 Files older than contract year 2019 can be purchased.

This dataset is comprised of data submitted to HCAI by prescription drug manufacturers for wholesale acquisition cost (WAC) increases that exceed the statutorily-mandated WAC increase threshold of an increase of more than 16% above the WAC of the drug product on December 31 of the calendar year three years prior to the current calendar year. This threshold applies to prescription drug products with a WAC greater than $40 for a course of therapy. Required WAC increase reports are to be submitted to HCAI within a month after the end of the quarter in which the WAC increase went into effect. Please see the statute and regulations for additional information regarding reporting thresholds and report due dates.

Key data elements in this dataset include the National Drug Code (NDC) maintained by the FDA, narrative descriptions of the reasons for the increase in WAC, and the five-year history of WAC increases for the NDC. A WAC Increase Report consists of 27 data elements that have been divided into two separate Excel data sets: Prescription Drug WAC Increase and Prescription Drug WAC Increase – 5 Year History. The datasets include manufacturer WAC Increase Reports received since January 1, 2019. The Prescription Drugs WAC Increase dataset consists of the information submitted by prescription drug manufacturers that pertains to the current WAC increase of a given report, including the amount of the current increase, the WAC after increase, and the effective date of the increase. The Prescription Drugs WAC Increase – 5 Year History dataset consists of the information submitted by prescription drug manufacturers for the data elements that comprise the 5-year history of WAC increases of a given report, including the amount of each increase and their effective dates.

There are 2 types of WAC Increase datasets below: Monthly and Annual. The Monthly datasets include the data in completed reports submitted by manufacturers for calendar year 2025, as of July 8, 2025. The Annual datasets include data in completed reports submitted by manufacturers for the specified year. The datasets may include reports that do not meet the specified minimum thresholds for reporting.

The Quick Guide explaining how to link the information in each data set to form complete reports is here: https://hcai.ca.gov/wp-content/uploads/2024/03/QuickGuide_LinkingTheDatasets.pdf

The program regulations are available here: https://hcai.ca.gov/wp-content/uploads/2024/03/CTRx-Regulations-Text.pdf

The data format and file specifications are available here: https://hcai.ca.gov/wp-content/uploads/2024/03/Format-and-File-Specifications-version-2.0-ada.pdf

DATA NOTES: Due to recent changes in Excel, it is not recommended that you save these files to .csv format. If you do, when importing back into Excel the leading zeros in the NDC number column will be dropped. If you need to save it into a different format other than .xlsx it must be .txt

DATA UPDATES: Annual datasets of reports from the preceding year are reviewed in the second half of the current year to identify if any revisions or additions have been made since the original release of the datasets. If revisions or additions have been found, an update of the datasets will be released. Datasets will be clearly marked with 'Updated' in their titles for convenient identification. Not all datasets may require an updated release. The review of previously released datasets will only be conducted once to determine if an updated release is necessary. Datasets with revisions or additions that may have been made after the one-time review can be requested. These requests should be sent via email to ctrx@hcai.ca.gov. Due to regulatory changes that went into effect April 1, 2024, reports submitted prior to April 1, 2024, will include the data field "Unit Sales Volume in US" and reports submitted on or after April 1, 2024, will instead include "Total Volume of Gross Sales in US Dollars".

The Quarterly Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information files contain formulary, pharmacy network, and pricing data for Medicare Prescription Drug Plans and Medicare Advantage (MA) Prescription Drug Plans (with the exception of employer and Program of All-Inclusive Care for the Elderly plans). Notice: CMS has identified an issue that resulted in a 15% coinsurance for plans with Defined Standard benefits to be listed rather than a 25% coinsurance in the Beneficiary Cost File under certain scenarios. This issue affected the 2023 Q4 to 2024 Q3 data. CMS will re-post the corrected data in batches between now and May 2025. These non-identifiable files are available on a quarterly basis and are comprised of the following tables: Plan Information - Information such as plan name, contract ID, plan ID, service area, and plan type. Geographic Locator - MA and Prescription Drug Plans region codes and county codes. Basic Drugs Formulary - Formulary details for each plan including National Drug Codes (NDCs), cost share tier level, and indicators for step therapy, quantity limits, and prior authorization. Excluded Drugs Formulary - Enhanced alternative plans may elect to provide a supplemental benefit and cover excluded drugs. File includes formulary details for excluded drugs that are covered by the plan (for enhanced alternative plans only). Beneficiary Cost - Plan level cost sharing details for preferred, non-preferred, and mail order network pharmacies. Pharmacy Network - National Provider Identifier (NPI) numbers for each network pharmacy including preferred, retail, and mail order indicators. Pricing - Plan level average monthly costs for formulary Part D drugs (note: this table is only available in the quarterly files). Indication Based Coverage Formulary File - Includes drugs covered based on FDA-approved indication for each plan. Insulin Beneficiary Cost File - Plan level cost sharing details for insulin at preferred, non-preferred and mail order network pharmacies. These are large files and can take time to download. Please read the “Agreement for Use” in the Resources section below. This document contains important information regarding timeframes for obtaining data as well as data accuracy and integrity. The Monthly Prescription Drug Plan Formulary and Pharmacy Network Information is also available to access for the monthly level information. Please note: The Part D benefit year information for plans become available in October of the year prior. For example, year 2024 data is available in the fourth quarter file of 2023. Year 2024 data continues to be available in the Q1-Q3 2024 files, then in the fourth quarter of 2024 year 2025 data becomes available. Estimated release dates for upcoming 2025 quarterly data (files reflect data for the quarter that ended the month before the file was released): 4/23/25 7/30/25 Files older than contract year 2019 can be purchased.

THPdb is a manually curated database of Food and Drug Administration (FDA) approved therapeutic peptide and proteins. The text file contain all the data curated in THPdb.

Database

This database collects measurements of liver transporter function derived from kinetic liver data measured with gadoxetate-enhanced MRI. The results were derived through a series of experiments by the liver workpackage of the TRISTAN consortium. The database is maintained by the open medical imaging biomarkers laboratory (miblab.org).

Subjects

Human healthy volunteers, patients and rats.

Background

The data are taken from a series of preclinical and clinical studies performed by the TRISTAN project, in the period 2018-2024. The aim of these studies was to test if the effect of drugs on uptake and excretory function of the liver can be measured reliably with dynamic gadoxetate-enhanced MRI. Combined these studies provide proof of concept for a new MRI-based biomarker to predict the risk of liver-mediated drug-drug interactions, and of drug-induced liver injury.

The data have been used to support a submission to the FDA's biomarker qualification program (details).

Format

All data are in dmr format - a folder with three csv files:

• data.csv: Data dictionary
• rois.csv: ROI curves
• pars.csv: Subject parameters

The data can be read and manipulated interactively with common applications such as excel, or programmatically with the python package pydmr.

Datasets

tristan_humans_healthy_rifampicin_all_results

Spreadsheet file with the results summary file as downloaded from LINCS, for the HDAC signature used to validate the software. (CSV 4259.84 kb)

Database

This database contains source data from a pilot study demonstrating the efficacy of MRI-based measurements of liver transporter function in detecting drug-mediated inhibition. The database is maintained by the open medical imaging biomarkers laboratory (miblab.org).

Subjects

Human healthy volunteers.

Background

The srudy is part of a series of preclinical and clinical studies performed by the TRISTAN project, in the period 2018-2024. The aim of these studies was to test if the effect of drugs on uptake and excretory function of the liver can be measured reliably with dynamic gadoxetate-enhanced MRI. Combined these studies provide proof of concept for a new MRI-based biomarker to predict the risk of liver-mediated drug-drug interactions, and of drug-induced liver injury.

The data have been used to support a submission to the FDA's biomarker qualification program (details).

Format

All data are in dmr format - a folder with three csv files:

• data.csv: Data dictionary
• pars.csv: Subject parameters

The data can be read and manipulated interactively with common applications such as excel, or programmatically with the python package pydmr.

Datasets

tristan_humans_healthy_rifampicin_data