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 connection	100	60 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

Operation ID:

DrugAdverseEvent

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

Operation ID:

DrugEnforcement

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

Operation ID:

DrugLabeling

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

Operation ID:

DrugNDC

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

Operation ID:

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.