openFDA Drug (Independent Publisher) (Preview)

openFDA is an Elasticsearch-based API that serves public FDA data about nouns like drugs, devices, and foods. Each of these nouns has one or more categories, which serve unique data-such as data about recall enforcement reports, or about adverse events. Every query to the API must go through one endpoint for one kind of data.

This connector is available in the following products and regions:

Service Class Regions
Logic Apps Standard All Logic Apps regions except the following:
     -   Azure Government regions
     -   Azure China regions
     -   US Department of Defense (DoD)
Power Automate Premium All Power Automate regions except the following:
     -   US Government (GCC)
     -   US Government (GCC High)
     -   China Cloud operated by 21Vianet
     -   US Department of Defense (DoD)
Power Apps Premium All Power Apps regions except the following:
     -   US Government (GCC)
     -   US Government (GCC High)
     -   China Cloud operated by 21Vianet
     -   US Department of Defense (DoD)
Contact
Name Woong Choi
Email Woong.Choi@sevensigma.com.au
Connector Metadata
Publisher Woong Choi
Website https://open.fda.gov
Privacy policy https://www.fda.gov/about-fda/about-website/website-policies#privacy
Categories Data

Throttling Limits

Name Calls Renewal Period
API calls per connection10060 seconds

Actions

Drug Adverse Event

The openFDA drug adverse event API returns data that has been collected from the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication error reports submitted to FDA.

Drug Enforcement

The openFDA drug enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information submitted to FDA. Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly.

Drug Labeling

Drug manufacturers and distributors submit documentation about their products to FDA in the Structured Product Labeling (SPL) format. The openFDA drug product labeling API returns data from this dataset.

Drug NDC

The openFDA drug NDC Directory endpoint returns data from the NDC Directory, a database that contains information on the National Drug Code (NDC). FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

DrugsFDA

DrugsFDA 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.

Drug Adverse Event

The openFDA drug adverse event API returns data that has been collected from the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication error reports submitted to FDA.

Parameters

Name Key Required Type Description
Search Query
search string

single

Number of records to be returned
limit integer

single

Returns

Name Path Type Description
disclaimer
meta.disclaimer string

Disclaimer

terms
meta.terms string

Terms of Service

license
meta.license string

Data Licensing

last_updated
meta.last_updated string

Last Update Date

skip
meta.results.skip integer

Number of skipped records

limit
meta.results.limit integer

Number of records to be returned

total
meta.results.total integer

Number of total records

results
results array of object

Results

receiptdateformat
results.receiptdateformat string

Receipt date format

receiver
results.receiver string

Receiver

seriousnessdeath
results.seriousnessdeath string

Adverse event resulted in death

companynumb
results.companynumb string

Identifier for the company providing the report.

receivedateformat
results.receivedateformat string

Encoding format of the transmissiondate field

reportercountry
results.primarysource.reportercountry string

Country from which the report was submitted.

qualification
results.primarysource.qualification string

Category of individual who submitted the report.

transmissiondateformat
results.transmissiondateformat string

Encoding format of the transmissiondate field.

fulfillexpeditecriteria
results.fulfillexpeditecriteria string

Identifies expedited reports (those that were processed within 15 days).

safetyreportid
results.safetyreportid string

The 8-digit Safety Report ID number, also known as the case report number or case ID.

senderorganization
results.sender.senderorganization string

Name of the organization sending the report.

receivedate
results.receivedate string

Date that the report was first received by FDA.

patientonsetage
results.patient.patientonsetage string

Age of the patient when the event first occured.

patientonsetageunit
results.patient.patientonsetageunit string

The unit for the interval in the field patientonsetage.

patientsex
results.patient.patientsex string

The sex of the patient.

patientdeathdateformat
results.patient.patientdeath.patientdeathdateformat string

Encoding format of the field patientdeathdate.

patientdeathdate
results.patient.patientdeath.patientdeathdate string

If the patient died, the date that the patient died

reaction
results.patient.reaction array of object

Reaction

reactionmeddrapt
results.patient.reaction.reactionmeddrapt string

Patient reaction, as a MedDRA term.

drug
results.patient.drug array of object

Drug

drugcharacterization
results.patient.drug.drugcharacterization string

Reported role of the drug in the adverse event report.

medicinalproduct
results.patient.drug.medicinalproduct string

Drug name.

drugauthorizationnumb
results.patient.drug.drugauthorizationnumb string

Drug authorization or application number (NDA or ANDA), if provided.

drugadministrationroute
results.patient.drug.drugadministrationroute string

The drug's route of administration.

drugindication
results.patient.drug.drugindication string

Indication for the drug's use.

transmissiondate
results.transmissiondate string

Date that the record was created.

serious
results.serious string

Seriousness of the adverse event.

receiptdate
results.receiptdate string

Date that the most recent information in the report was received by FDA.

Drug Enforcement

The openFDA drug enforcement reports API returns data from the FDA Recall Enterprise System (RES), a database that contains information on recall event information submitted to FDA. Currently, this data covers publicly releasable records from 2004-present. The data is updated weekly.

Parameters

Name Key Required Type Description
Search Query
search string

single

Number of records to be returned
limit integer

single

Returns

Name Path Type Description
disclaimer
meta.disclaimer string

Disclaimer

terms
meta.terms string

Terms of Service

license
meta.license string

Data Licensing

last_updated
meta.last_updated string

Last Update Date

skip
meta.results.skip integer

Number of skipped records

limit
meta.results.limit integer

Number of records to be returned

total
meta.results.total integer

Number of total records

results
results array of object

Results

country
results.country string

The country in which the recalling firm is located.

city
results.city string

The city in which the recalling firm is located.

address_1
results.address_1 string

This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

reason_for_recall
results.reason_for_recall string

Information describing how the product is defective and violates the FD&C Act or related statutes.

address_2
results.address_2 string

This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

product_quantity
results.product_quantity string

The amount of defective product subject to recall.

code_info
results.code_info string

A list of all lot and/or serial numbers, product numbers, packer or manufacturer numbers, sell or use by dates, etc., which appear on the product or its labeling.

center_classification_date
results.center_classification_date string

Center classification date

distribution_pattern
results.distribution_pattern string

General area of initial distribution such as, “Distributors in 6 states: NY, VA, TX, GA, FL and MA; the Virgin Islands; Canada and Japan”. The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.

state
results.state string

The U.S. state in which the recalling firm is located.

product_description
results.product_description string

Brief description of the product being recalled.

report_date
results.report_date string

Date that the FDA issued the enforcement report for the product recall.

classification
results.classification string

Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard.

recalling_firm
results.recalling_firm string

The firm that initiates a recall or, in the case of an FDA requested recall or FDA mandated recall, the firm that has primary responsibility for the manufacture and (or) marketing of the product to be recalled.

recall_number
results.recall_number string

A numerical designation assigned by FDA to a specific recall event used for tracking purposes.

initial_firm_notification
results.initial_firm_notification string

The method(s) by which the firm initially notified the public or their consignees of a recall. A consignee is a person or firm named in a bill of lading to whom or to whose order the product has or will be delivered.

product_type
results.product_type string

Product type

event_id
results.event_id string

A numerical designation assigned by FDA to a specific recall event used for tracking purposes.

termination_date
results.termination_date string

Termination date

more_code_info
results.more_code_info string

More code info

recall_initiation_date
results.recall_initiation_date string

Date that the firm first began notifying the public or their consignees of the recall.

postal_code
results.postal_code string

Postal code

voluntary_mandated
results.voluntary_mandated string

Describes who initiated the recall. Recalls are almost always voluntary, meaning initiated by a firm. A recall is deemed voluntary when the firm voluntarily removes or corrects marketed products or the FDA requests the marketed products be removed or corrected. A recall is mandated when the firm was ordered by the FDA to remove or correct the marketed products, under section 518(e) of the FD&C Act, National Childhood Vaccine Injury Act of 1986, 21 CFR 1271.440, Infant Formula Act of 1980 and its 1986 amendments, or the Food Safety Modernization Act (FSMA).

status
results.status string

This is an .exact field. It has been indexed both as its exact string content, and also tokenized.

Drug Labeling

Drug manufacturers and distributors submit documentation about their products to FDA in the Structured Product Labeling (SPL) format. The openFDA drug product labeling API returns data from this dataset.

Parameters

Name Key Required Type Description
Search Query
search string

single

Number of records to be returned
limit integer

single

Returns

Name Path Type Description
disclaimer
meta.disclaimer string

Disclaimer

terms
meta.terms string

Terms of Service

license
meta.license string

Data Licensing

last_updated
meta.last_updated string

Last Update Date

skip
meta.results.skip integer

Number of skipped records

limit
meta.results.limit integer

Number of records to be returned

total
meta.results.total integer

Number of total records

results
results array of object

Results

effective_time
results.effective_time string

Date reference to the particular version of the labeling document.

inactive_ingredient
results.inactive_ingredient array of string

A list of inactive, non-medicinal ingredients in a drug product.

references
results.references array of string

This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.

purpose
results.purpose array of string

Information about the drug product's indications for use.

keep_out_of_reach_of_children
results.keep_out_of_reach_of_children array of string

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.

warnings
results.warnings array of string

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.

spl_product_data_elements
results.spl_product_data_elements array of string

Usually a list of ingredients in a drug product.

other_safety_information
results.other_safety_information array of string

Information about safe use and handling of the product that may not have been specified in another field.

version
results.version string

A sequentially increasing number identifying the particular version of a document, starting with 1.

dosage_and_administration
results.dosage_and_administration array of string

Information about the drug product's dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.

pregnancy_or_breast_feeding
results.pregnancy_or_breast_feeding array of string

Documentation forthcoming.

stop_use
results.stop_use array of string

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.

package_label_principal_display_panel
results.package_label_principal_display_panel array of string

The content of the principal display panel of the product package, usually including the product's name, dosage forms, and other key information about the drug product.

indications_and_usage
results.indications_and_usage array of string

A statement of each of the drug product's indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.

set_id
results.set_id string

The Set ID, A globally unique identifier (GUID) for the labeling, stable across all versions or revisions.

id
results.id string

The document ID, A globally unique identifier (GUID) for the particular revision of a labeling document.

active_ingredient
results.active_ingredient array of string

A list of the active, medicinal ingredients in the drug product.

dosage_and_administration_table
results.dosage_and_administration_table array of string

Information about the drug product's dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.

Drug NDC

The openFDA drug NDC Directory endpoint returns data from the NDC Directory, a database that contains information on the National Drug Code (NDC). FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

Parameters

Name Key Required Type Description
Search Query
search string

single

Number of records to be returned
limit integer

single

Returns

Name Path Type Description
disclaimer
meta.disclaimer string

Disclaimer

terms
meta.terms string

Terms of Service

license
meta.license string

Data Licensing

last_updated
meta.last_updated string

Last Update Date

skip
meta.results.skip integer

Number of skipped records

limit
meta.results.limit integer

Number of records to be returned

total
meta.results.total integer

Number of total records

results
results array of object

Results

product_ndc
results.product_ndc string

The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen.

generic_name
results.generic_name string

Generic name(s) of the drug product.

labeler_name
results.labeler_name string

Labeler name of the drug product.

brand_name
results.brand_name string

Brand or trade name of the drug product.

active_ingredients
results.active_ingredients array of object

Active Ingredients

name
results.active_ingredients.name string

The names of the active, medicinal ingredients in the drug product.

strength
results.active_ingredients.strength string

The strength of the active, medicinal ingredients in the drug product.

finished
results.finished boolean

finished

packaging
results.packaging array of object

Packaging

package_ndc
results.packaging.package_ndc string

This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.

description
results.packaging.description string

A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

marketing_start_date
results.packaging.marketing_start_date string

This is the date that the labeler indicates was the start of its marketing of the drug product.

sample
results.packaging.sample boolean

Indicates whether this is a sample packaging or not.

listing_expiration_date
results.listing_expiration_date string

This is the date when the listing record will expire if not updated or certified by the firm.

manufacturer_name
results.openfda.manufacturer_name array of string

Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.

rxcui
results.openfda.rxcui array of string

The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.

spl_set_id
results.openfda.spl_set_id array of string

Unique identifier for the Structured Product Label for a product, which is stable across versions of the label. Also referred to as the set ID.

nui
results.openfda.nui array of string

Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).

pharm_class_epc
results.openfda.pharm_class_epc array of string

Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by [EPC] (such as Thiazide Diuretic [EPC] or Tumor Necrosis Factor Blocker [EPC].

pharm_class_pe
results.openfda.pharm_class_pe array of string

Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug's established pharmacologic class. Takes the form of the effect, followed by [PE] (such as Increased Diuresis [PE] or Decreased Cytokine Activity [PE].

unii
results.openfda.unii array of string

Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information.

marketing_category
results.marketing_category string

Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug.

dosage_form
results.dosage_form string

The drug's dosage form. There is no standard, but values may include terms like tablet or solution for injection.

spl_id
results.spl_id string

Unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID.

product_type
results.product_type string

Type of drug product

route
results.route array of string

The route of administation of the drug product.

marketing_start_date
results.marketing_start_date string

This is the date that the labeler indicates was the start of its marketing of the drug product.

product_id
results.product_id string

ProductID is a concatenation of the NDC product code and SPL documentID.

application_number
results.application_number string

This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

brand_name_base
results.brand_name_base string

The base of the brand name excluding its suffix.

pharm_class
results.pharm_class array of string

These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

DrugsFDA

DrugsFDA 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.

Parameters

Name Key Required Type Description
Search Query
search string

single

Number of records to be returned
limit integer

single

Returns

Name Path Type Description
disclaimer
meta.disclaimer string

Disclaimer

terms
meta.terms string

Terms of Service

license
meta.license string

Data Licensing

last_updated
meta.last_updated string

Last Update Date

skip
meta.results.skip integer

Number of skipped records

limit
meta.results.limit integer

Number of records to be returned

total
meta.results.total integer

Number of total records

results
results array of object

Results

submissions
results.submissions array of object

Submissions

submission_type
results.submissions.submission_type string

The type of the individual submission. Used in combination with submission_number.

submission_number
results.submissions.submission_number string

A unique identifier for each submission under that application.

submission_status
results.submissions.submission_status string

The current status of this submission.

submission_status_date
results.submissions.submission_status_date string

The date the status was applied to the submission.

submission_class_code
results.submissions.submission_class_code string

The Submission Classification Code, previously known as the Chemistry Classification Code, is assigned as a “Type” code.

submission_class_code_description
results.submissions.submission_class_code_description string

The Submission Classification Code, previously known as the Chemistry Classification Code, is assigned as a “Type” code. This is a full description of the classification code.

application_number
results.application_number string

This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

sponsor_name
results.sponsor_name string

The company that submitted an application to FDA for approval to market the drug product in the United States.

products
results.products array of object

Products

product_number
results.products.product_number string

A product number is assigned to each drug product associated with an NDA (New Drug Application), ANDA (Abbreviated New Drug Application) and Biologic License Application (BLA) . If a drug product is available in multiple strengths, there are multiple product numbers.

reference_drug
results.products.reference_drug string

Indicates whether the drug product is a reference drug.

brand_name
results.products.brand_name string

Brand or trade name of the drug product.

active_ingredients
results.products.active_ingredients array of object

Active ingredients

name
results.products.active_ingredients.name string

The names of the active, medicinal ingredients in the drug product.

strength
results.products.active_ingredients.strength string

The strength of the active, medicinal ingredients in the drug product.

reference_standard
results.products.reference_standard string

Indicates whether the drug product is a reference standard.

dosage_form
results.products.dosage_form string

The drug’s dosage form. There is no standard, but values may include terms like tablet or solution for injection.

route
results.products.route string

The route of administation of the drug product.

marketing_status
results.products.marketing_status string

Indicates how a drug product is sold in the United States.