Questions tagged [openfda]

Questions and answers surrounding the U.S. Food and Drug Administration's OpenFDA program.

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Query/Endpoint To Show Available Packaging Quantities

I'm currently trying to find the appropriate query or dataset to see all the packaging options (specifically quantities) for a particular drug. Example: Clotrimazole This drug comes in both creams and ...
4 votes
0 answers
165 views

Is there an API for drug approval packages from the FDA?

I am building an application where we'd like to reuse information from drug approval packages (Example). The FDA API does not have a query interface for drug approval packages. Is there an ...
0 votes
1 answer
35 views

Querying FDA Using NDC

Would someone be able to guide me on how to create the right query to find a pill's metadata based on NHC. Here the combinations I tried but all return no results. Identifier: 51285-0092-87_BE305F72 ...
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1 answer
22 views

Manage Missing FDA Drug Labels from New Update Files

I am using Drug Labeling [/drug/label] at OpenFDA to ingest the updated files. I understand I need to re-ingest all the files every time there is a release and update the previously built database. My ...
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1 answer
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OpenFDA Prior Notice

Is it possible to create Prior Notices using OpenFDA? I've search the API documentation and this forum, but haven't found any topics about this. BR Michael Sandström
2 votes
1 answer
53 views

Incorrect Product Code in OpenFDA Recalls Database

I noticed that when I look at product recall "Z-1973-2012" in the OpenFDA Recalls database, it returns with a result containing Product Code "CGA". However the same recall number on FDA's Recall ...
1 vote
1 answer
188 views

Difference between Inspection Observation and Inspection Citation reports

What is the difference between the FDA Inspection Observation and Inspection Citation reports? The inspection citation report appears to have slightly less data but provides more details for what is ...
0 votes
1 answer
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Uniquely Identify Items in OpenFDA (MAUDE)

Im downloading and processing the complete data of OpenFDA as described in: https://open.fda.gov/apis/downloads/ https://api.fda.gov/download.json But i could not find a way to uniquely identify the ...
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1 answer
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Is there an identifier that might indicate 505(b)(1) vs 505(b)(2) filing?

I'm skimming through the Drugs@FDA dataset, and I'm wondering if any of the identifiers would tell me which pathway the application went through. Of the options, SubmissionClassCodeID seems most ...
1 vote
1 answer
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Is "event_key" meant to be empty?

If you review the raw data documentation and any accompanying research papers, you will be informed that "event_key" is meant to be an important field. Master Event Data: A distinct master event data ...
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1 answer
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Using the openfda API, is there a way to download the 510(k) summary documents using the API? Or simple get the links to those summaries?

I can use the API to determine if a "statement_or_summary" exists. Is there a way to download the 510(k) summary documents, or get links to those documents? I am fine ignoring the documents ...
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1 answer
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openfda results in spl_patient_package_insert_table not rendering HTML correctly

I'm accessing the spl_patient_package_insert_table data in the https://api.fda.gov/drug/label.json endpoint. The HTML returned in this field is not rendering correctly in a browser. Does this ...
1 vote
1 answer
99 views

The openFDA API supports searching by range in date not working?

I would like to create an URL, that shows me all reports from the MAUDE database from December with the product key 'MQB'. I created the this URL as an attempt: https://api.fda.gov/device/recall.json?...
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1 answer
44 views

The difference between exact with suffix and without suffix

Can you explain the difference between searching on OpenFDA with the .exact suffix, and without the suffix? I'm a little confused
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1 answer
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FDA Api Issue with Brackets

When I'm making what seems like a working query: https://api.fda.gov/food/enforcement.json?api_key=123&search=report_date:[2021111+TO+20211112] I get an error: [token_mgr_error] token_mgr_error: ...
1 vote
1 answer
72 views

openFDA - Open APIs to access Import Alerts, Import Refusals, Warning Letters & Inspection details

Does openFDA have APIs to access Import Alerts, Import Refusals, Warning Letters & Inspection details for a Supplier?
1 vote
1 answer
65 views

Total Product Life Cycle API?

I am unable to find any endpoint(s) to fetch TPLC related details in the OpenFDA website or may be i've overlooked. Is there is an API or other ways to retrieve TPLC related details, could you pls ...
0 votes
1 answer
22 views

How do you use the sorting function in OpenFDA for registration listing?

Can you sort "sort=receivedate:desc&limit=10" under the registration listing for product.created_date?
1 vote
1 answer
64 views

openFDA API query including "\"

I came across a question. Some of the generic_name contains backward slash sign, for example, CYCLOPHOSPHAMIDE\PREDNISONE\VINCRISTINE. How to construct the API query that can include backward slash ...
1 vote
2 answers
97 views

OpenFDA NDC endpoint has multiple RXCUI values for a single product NDC

I'm currently operating under the assumption that any two NDCs with the same RxCUI value are pharmaceutical equivalents. Hopefully that's correct. When querying the NDC data from OpenFDA, I noticed ...
1 vote
2 answers
55 views

How to inquire about adverse events of aspirin in the open FDA?

I want to check the adverse events of aspirin drugs in the open fda data within the specified date I have tried many times and it keeps getting an error display Where did I go wrong ? How can I query ...
1 vote
1 answer
96 views

openFDA decision_code field in PMA device API endpoint

I downloaded the PMA devices dataset from here https://download.open.fda.gov/device/pma/device-pma-0001-of-0001.json.zip However, It seems like the denied filings were not included since the ...
1 vote
1 answer
79 views

Device Product Code API call

I'm trying to return medical device "product_code" data, but the following two URLs do not work. For example, I'm trying to get data on the product code, "DXN" as listed here: https://www.accessdata....
1 vote
2 answers
74 views

How to download a subset of the reports based on a specific indication of query term?

I understand that for performance purposes in my case it will be better to download the data rather than accessing it through the public API. On a practical note I am only interested in a subset of ...
1 vote
1 answer
254 views

Can I use openFDA API for Drugs side effects?

Is there any way to get Drugs side effect for specific drug name like Paxil from openFDA API. I read the documentation but don't really understand
1 vote
1 answer
67 views

Retrieve the Supplier details using FEI number?

a. Can we retrieve the Supplier details using FEI number, in any of the APIs? b. Are there any datasets or APIs available to query information under Cosmetics? c. Are there any open APIs to fetch ...
1 vote
1 answer
67 views

How to know which drug product is a reference listed drug (RLD)?

I trying to figure out how to know which drug product is a reference listed drug (RLD). Let's take for an example following spl_set_id: https://api.fda.gov/drug/drugsfda.json?search=products....
1 vote
1 answer
154 views

Can we get the dosage list for a drug

How can we get the dosage list for a particular drug. we have the key "dosage_forms_and_strength" but it gives a single string not in a list format. I need to bind a dropdown for dosage information ...
1 vote
1 answer
119 views

NDC - SETID Mapping

I am interested in connecting the NDC data (brand_name, labeler etc.) to the FDA Label data (SET_ID). However, I'm struggling to find a dataset that would contain the mapping between the NDC code and ...
0 votes
3 answers
107 views

Missing certain data in API

We are using the below API to fetch data based on dates: https://api.fda.gov/device/event.json?api_key=MyAPIKey&search=date_received:[20230702+TO+20230704]AND+device.device_report_product_code....
0 votes
1 answer
37 views

Cant Search By NDC String

Hello I know this may be a dumb question but I would like to search for a drug by the NDC like this https://api.fda.gov/drug/ndc.json?search=product_ndc:"54868-4517"&limit=100 but I get ...
0 votes
1 answer
25 views

Some 510k records with 'statement' value stored in the summary searchable field from openFDA do not have summary information from FDA database

I see there is a searchable field called 'summary_or_statement' from openFDA API to indicate the summary or statement result. However, some records with "statement' value for the ...
0 votes
2 answers
28 views

How do make an autocomplete for drug search?

I am making a drug search box on a webapp and was wondering if there is a way to make an autocomplete as a user type the drug name in the searchbox? This is the api url that i use to search for ...
2 votes
3 answers
207 views

openFDA: Is There an Open Database of Which Drugs are Approved for the Treatment of Which Illnesses?

Is there an open database which lists FDA or EMA approvals of drugs for the treatment of specific illnesses?
0 votes
1 answer
149 views

(Drug API with NDC) Drug name with specified strength & NDC Error

Our website is a platform for patients to consult with physicians and specialists on-demand. The doctors will be able to search for the drug name though the database (NDCID drug database integrated in ...
0 votes
1 answer
29 views

No inactive_ingredient field when query for drug substance in Drug Label API

I am looking for the inactive ingredients for a dozen of different drugs. However when querying in the Label API, most results return without an "inactive_ingredient" field. The field only ...
0 votes
1 answer
81 views

OpenFDA - Parsing Indications and Dosage Variables

I have a question about parsing two specific variables from the Product Labeling Endpoint on OpenFDA: indications_and_usage dosage_and_administration Ideally I would like to: Extract each ...
2 votes
1 answer
82 views

openfda: query to obtain links to 510(k) summaries

Using the api for the 510(k) database in openfda, I can search the statement_or_summary field and find all the rows (i.e. devices) with summaries. But in the download, the api just produces the ...
1 vote
1 answer
69 views

API returns code not found

For a number of codes found in the National Drug Code directory the API returns code not found. https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm I have reviewed the API documentation and ...
1 vote
1 answer
52 views

How would one leverage the OpenFDA API to obtain listing of all recalls associated with a specific CIED?

How would one leverage the OpenFDA API to obtain listing of all recalls associated with a specific CIED? We have limited info on each device such as the model of implanted device and serial number. ...
0 votes
1 answer
27 views

Is there a way to extract NCT ID, approval order, post-approval study links from PMA database with openFDA api?

I am wondering if it is possible to add more searchable fields to the openFDA api PMA database such as NCT ID, approval order link and post-approval study link? Or adding something to determine which ...
0 votes
1 answer
43 views

Device recalls - difference between date entry was created in openFDA database and date manufacturer informed about recall

I am using the recalls database to always be aware of the recalls for some specific vendors and products. This is the call I am doing: https://api.fda.gov/device/recall.json?search=recalling_firm:(&...
1 vote
1 answer
46 views

510(k) Clearance Data Set seems to end as of June 1, 2023

Over the last month or so, I have downloaded the 510(k) dataset several times, and each time it seems to be lacking any 510(k)s decided after June 1, 2023. https://open.fda.gov/apis/device/510k/...
1 vote
1 answer
28 views

Filtering Drug Adverse Events to Focus on Combination Products

The openFDA drug adverse event API returns data that has been collected from the FDA Adverse Event Reporting System (FAERS). The FAERS data in the DTD Descriptor contains a field that identifies ...
0 votes
1 answer
28 views

Patient age is not displayed correctly

Patient Age is displayed as below: Patient Age 19710 DA using the below URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=16232230&pc=CCK&device_sequence_no=...
0 votes
1 answer
69 views

mdr text is missing for many report numbers

I am using the below mentioned adverse event device open API url but it is not giving MDR text for many report numbers like 2112667-2023-03226, 2112667-2023-03227, 2112667-2023-03228 etc though the ...
0 votes
1 answer
28 views

Why does device.device_report_product_code require = rather than :?

To successfully search the device/event endpoint for device.device_report_product_code, you must search using = instead of : like this: https://api.fda.gov/device/event.json?search=device....
0 votes
1 answer
25 views

FDA API not working since last month

The FDA API is not able to extract data for the month of May and June. The API used in collecting the data for May is given below: 'https://api.fda.gov/device/event.json?search=date_received:[20230501+...
1 vote
1 answer
97 views

How to format openFDA API results?

I am able to retrieve the results for a drug from the openFDA via PHP; however the results are just strings of text without any indicators for formatting such as html tags or splitting them up into ...
1 vote
1 answer
155 views

Why does the data on website not match what is returned from the api

I am trying to get data similar to what is shown on https://www.fda.gov/Safety/Recalls/default.htm using the api, but I am seeing a lot of discrepancies. For example when I use the following api ...

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