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21 U.S. Code § 360eee / GS1 EPCIS <2ms Edge Edge 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. This specification documents the exact field layout, checksum rules, and validation behavior so your integration matches 21 U.S. Code § 360eee / GS1 EPCIS without reading the source standard.

Latency: <2ms Edge Availability: 99.99% Standard: 21 CFR 201.25 In-Memory Execution
Interactive Edge Workbench

⚡ Live FDA 21 CFR 201.25 Barcode Requirement & 2D DataMatrix Spec Interactive Workbench

Test real-time validation and schema parsing for FDA 21 CFR 201.25 Barcode Requirement & 2D DataMatrix Spec directly in your browser. Runs in sub-5ms with zero setup.

32KB Demo Cap 60 req/min Burst <2ms V8 Compute Zero Data Retention
input.txt 0 B
output.json demo-ready
Status: Ready
{
  "status": "Click RUN VALIDATION to execute on the Cloudflare edge..."
}
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LLM / MCP
Prompt-Ready Specification for AI Agents llms.txt
Structured format rules and schemas optimized for LLM coding agents and Model Context Protocol tooling.
Raw .md
Official Standard & Validation Protocol Authority: U.S. Food & Drug Administration (FDA) DSCSA ↗

Quick Summary: Automated compliance validator for US FDA 21 CFR 201.25 drug product barcode labeling regulations. Validates strictly against 21 U.S. Code § 360eee / GS1 EPCIS with sub-5ms in-memory response times.

Latency
<2ms Edge
Standard
21 CFR 201.25
Version
Max Payload
512 KB
Privacy
In-Memory (0 bytes stored)

Specification & Structural Breakdown

Technical Summary: Validates strictly against 21 U.S. Code § 360eee / GS1 EPCIS. Payloads are parsed in memory and return clean, typed JSON in milliseconds with zero data logged.

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

Parsed JSON Response Model

The edge microservice transforms input payloads into strongly-typed hierarchical JSON envelopes with sub-5ms latency:

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

Copy-Paste Integration Code (6 Languages)

Integrate FDA 21 CFR 201.25 Barcode Requirement & 2D DataMatrix Spec directly into your production application with native, zero-dependency code snippets in cURL, Node.js, Python, Go, C#, and a ready-to-paste Claude prompt. Get a free API key → (no credit card required):

curl --request POST \
  --url "https://api.stanzaapi.com/pharma-dscsa/api/v1/dscsa/validate-barcode" \
  --header "Content-Type: application/json" \
  --header "x-api-key: YOUR_API_KEY" \
  --data '{
  "rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
}'
const response = await fetch("https://api.stanzaapi.com/pharma-dscsa/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);
import requests
import json

url = "https://api.stanzaapi.com/pharma-dscsa/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())
package main

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

func main() {
	url := "https://api.stanzaapi.com/pharma-dscsa/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))
}
using System;
using System.Net.Http;
using System.Text;
using System.Threading.Tasks;

class Program
{
    static async Task Main()
    {
        using var client = new HttpClient();
        client.DefaultRequestHeaders.Add("x-api-key", Environment.GetEnvironmentVariable("API_KEY") ?? "YOUR_API_KEY");

        var json = @"{""rawBarcode"":""010030123456789621123456789012\u001d1726083110LOT99881""}";
        var payload = new StringContent(json, Encoding.UTF8, "application/json");

        var response = await client.PostAsync("https://api.stanzaapi.com/pharma-dscsa/api/v1/dscsa/validate-barcode", payload);
        var content = await response.Content.ReadAsStringAsync();
        Console.WriteLine(content);
    }
}
Integrate the StanzaAPI pharma-dscsa micro-API.

Endpoint: POST https://api.stanzaapi.com/pharma-dscsa/api/v1/dscsa/validate-barcode
Auth header: x-api-key: YOUR_API_KEY
Content-Type: application/json
Request body:
{
  "rawBarcode": "010030123456789621123456789012\u001d1726083110LOT99881"
}

Rules:
- Send the request with a 2-second timeout.
- Parse the standard envelope { success, data, meta: { latency_ms, version } }.
- On failure, read { success: false, error, code } and branch on the code.
- Do not retry 4xx responses; surface the error code to the caller.
- Treat invalid-but-well-formed payloads as HTTP 200 with data.valid === false.

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:

Complementary Enterprise APIs

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All FDA DSCSA & EU FMD Prescription Drug Serialization API Formats & Specifications (6) Directory Index ↓
GS1 Verification Router Service (VRS) Lightweight Messaging Spec EPCIS 1.2 XML Event Parser & Schema Validator (FDA DSCSA) EPCIS 2.0 JSON-LD Supply Chain Event Parser & Validator FDA 21 CFR 201.25 Barcode Requirement & 2D DataMatrix Spec DSCSA 4-Element 2D DataMatrix Barcode & Matrix Specification DSCSA Section 582 Suspect Product Quarantine & Verification Rules