querying-openfda-labels

Querying OpenFDA drug labels, NDC, and recalls

Once OpenMed has pulled a drug name out of a note, you often need authoritative product facts: the boxed warning, approved indications, dosage form / route, package NDC codes, and whether the product is under recall. The FDA's OpenFDA API exposes the Structured Product Labeling (SPL), the NDC directory, and enforcement (recall) reports — all public and free.

This skill is enrichment: it attaches regulatory facts to an extracted drug. It is not clinical decision support — a label lookup informs a human, it does not prescribe.

When to use

• You extracted a drug and need its boxed warning or indications for display, alerting, or expectedness checks.
• You need NDC package codes, dosage form, or route for a product.
• You want to know if a drug/lot is under an open recall (enforcement).
• You want to map a brand name to its generic ingredient and RxCUI via the label's openfda block.

The three endpoints

No key needed to try it (240 req/min, 1,000/day per IP). A free api_key= raises the daily cap to 120,000.

Quick start (real OpenFDA queries)

import requests

def openfda(endpoint: str, search: str, limit: int = 1) -> list[dict]:
    url = f"https://api.fda.gov/drug/{endpoint}.json"
    r = requests.get(url, params={"search": search, "limit": limit}, timeout=30)
    if r.status_code == 404:        # OpenFDA returns 404 for zero matches
        return []
    r.raise_for_status()
    return r.json().get("results", [])

# 1) Label: boxed warning + indications for a generic drug.
label = openfda("label", 'openfda.generic_name:"warfarin"')
if label:
    rec = label[0]
    print("Boxed warning:", rec.get("boxed_warning", ["(none)"])[0][:200])
    print("Indication:", rec.get("indications_and_usage", ["(none)"])[0][:200])
    print("RxCUI:", rec.get("openfda", {}).get("rxcui"))

# 2) NDC: package codes, form, route.
ndc = openfda("ndc", 'generic_name:"warfarin"', limit=5)
for rec in ndc:
    print(rec["product_ndc"], rec.get("dosage_form"), rec.get("route"))

# 3) Enforcement: open recalls for a product.
recalls = openfda("enforcement",
                  'product_description:"warfarin"+AND+status:"Ongoing"', limit=5)
for rec in recalls:
    print(rec["classification"], "-", rec["reason_for_recall"][:120])