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Latency: <2ms Edge Availability: 99.99% Standard: 21 CFR 201.25 V8 Pure Compute

FDA 21 CFR 201.25 Barcode Requirement & 2D DataMatrix Spec

Automated compliance validator for US FDA 21 CFR 201.25 drug product barcode labeling regulations.

Official Regulatory Standard & Verification Protocol Authority: U.S. Food & Drug Administration (FDA) DSCSA ↗

Quick Technical Summary: Automated compliance validator for US FDA 21 CFR 201.25 drug product barcode labeling regulations. Implementation conforms to 21 U.S. Code § 360eee / GS1 EPCIS.

Execution SLA
<2ms Edge (Cloudflare V8)
Governing Norm
21 CFR 201.25
Throughput Limit
512 KB / Payload
Data Privacy
100% In-Memory (Zero Store)

Specification & Structural Breakdown

21 CFR 201.25 mandates that certain human drug and biological products bear a machine-readable barcode containing the National Drug Code (NDC).

RequirementRegulationSpecificationFormat
Machine Readable NDC21 CFR 201.25Linear or 2D Matrix barcodeGTIN-14 / GS1-128 / DataMatrix
Human Readable Text21 CFR 201.57Product identifier printed in clear textNDC, SN, EXP, LOT
Interactive Edge Validator

Test FDA 21 CFR 201.25 Barcode Requirement & 2D DataMatrix Spec Live

Paste raw inputs up to 32KB and inspect deterministic parsed JSON in real-time across 330+ Cloudflare edge locations. Pure compute, zero cold-starts.

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Parsed JSON Response Model

The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:

HTTP 200 JSON Payload
{
  "regulation": "21 CFR 201.25",
  "complianceStatus": "PASS",
  "ndc": "01234-567-89",
  "gtin": "00301234567896",
  "machineReadableValid": true
}

Copy-Paste Integration Code

Integrate this validator directly into your application using your production API key:

cURL
curl --request POST \
  --url "https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode" \
  --header "Content-Type: application/json" \
  --header "x-api-key: YOUR_API_KEY" \
  --data '{
  "rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
}'
Node.js (Fetch)
const response = await fetch("https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode", {
  method: "POST",
  headers: {
    "Content-Type": "application/json",
    "x-api-key": process.env.API_KEY || "YOUR_API_KEY"
  },
  body: JSON.stringify({
  "rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
})
});

const data = await response.json();
console.log(data);
Python (Requests)
import requests
import json

url = "https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode"
headers = {
    "Content-Type": "application/json",
    "x-api-key": "YOUR_API_KEY"
}
payload = {
    "rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
}

response = requests.post(url, json=payload, headers=headers)
print(response.json())
Go
package main

import (
	"bytes"
	"fmt"
	"io"
	"net/http"
	"os"
)

func main() {
	url := "https://fda-dscsa-eu-fmd-drug-serialization-api-21-usc-360eee.stanzaapi.com/api/v1/dscsa/validate-barcode"
	payload := []byte(`{"rawBarcode":"010030123456789621123456789012\u001d1726083110LOT99881"}`)

	req, _ := http.NewRequest("POST", url, bytes.NewBuffer(payload))
	req.Header.Add("Content-Type", "application/json")
	req.Header.Add("x-api-key", os.Getenv("API_KEY"))

	res, err := http.DefaultClient.Do(req)
	if err != nil {
		panic(err)
	}
	defer res.Body.Close()
	body, _ := io.ReadAll(res.Body)
	fmt.Println(string(body))
}

Frequently Asked Questions & Technical Notes

Does 21 CFR 201 apply to over-the-counter (OTC) drugs?

Yes, certain OTC medications and all prescription biologics are covered under 21 CFR 201.

Related FDA DSCSA & EU FMD Prescription Drug Serialization API Formats

Explore sibling specifications and standards in the same developer cluster: