querying-openfda-labels

Retrieve FDA drug labels, NDC records, and recall information via OpenFDA API.

5.0k|615|Updated Oct 4, 2025
One-click install
npx skills add https://github.com/maziyarpanahi/openmed --skill querying-openfda-labels
Or copy as Structured Prompt for Agent
Please help me install this Agent Skill.
Skill: querying-openfda-labels
Source: https://github.com/maziyarpanahi/openmed/tree/main/skills/querying-openfda-labels
Command: npx skills add https://github.com/maziyarpanahi/openmed --skill querying-openfda-labels

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This Skill helps users quickly retrieve authoritative FDA drug information without manually searching prescribing labels, NDC records, or recall notices, while keeping clinical notes de-identified.

Core Features & Use Cases

  • Label Lookup: Retrieve boxed warnings, approved indications, dosage instructions, warnings, brand names, generic names, and RxCUI identifiers from OpenFDA drug labels.
  • NDC and Recall Enrichment: Find package NDC codes, dosage forms, administration routes, active ingredients, and ongoing enforcement actions, including Class I, II, and III recalls.
  • Clinical Data Workflow: Enrich drug entities extracted by OpenMed and connect normalized RxNorm ingredients or RxCUIs to regulatory product facts for pharmacovigilance and safety review.
  • Use Case: After extracting warfarin from a de-identified clinical note, use this Skill to retrieve its boxed warning, indications, package information, and active FDA recall records.

Quick Start

Use the querying-openfda-labels skill to look up the boxed warning, indications, NDC information, and ongoing recalls for warfarin.

Frequently Asked Questions about querying-openfda-labels

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I retrieve FDA drug labels and boxed warnings using generic names or RxCUIs?

Retrieve FDA drug labels by querying the OpenFDA API with de-identified generic names, brand names, or RxCUIs. This process returns boxed warnings, approved indications, and dosage instructions while handling 404 no-match responses for unmatched medications.

What is the best way to look up NDC directory records and active drug recalls from OpenFDA?

Look up NDC directory records and active drug recalls from OpenFDA by searching with normalized drug identifiers. This retrieves package NDC codes, dosage forms, administration routes, and ongoing Class I, II, and III enforcement actions for the identified medication.

Can I use OpenFDA API queries for pharmacovigilance and safety screening?

Yes, you can use OpenFDA API queries for pharmacovigilance and safety screening by retrieving authoritative regulatory product facts. Connecting normalized RxNorm ingredients or RxCUIs to FDA labels and recall records enables comprehensive safety reviews of de-identified clinical medications.

Does querying OpenFDA drug labels require handling rate limits and multi-value fields?

Querying OpenFDA drug labels requires handling API rate limits, multi-value label fields, and normalization of NDC and recall status data. You also need OpenFDA API access and de-identified drug queries to properly process the returned regulatory information.

Why does my OpenFDA drug label lookup return a 404 no-match response?

OpenFDA drug label lookups return a 404 no-match response when the queried generic name, brand name, or RxCUI does not match any records in the FDA database. The query process requires handling these responses and verifying the normalized drug identifier.