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.
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{
"status": "Click RUN VALIDATION to execute on the Cloudflare edge..."
}
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.
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).
| Requirement | Regulation | Specification | Format |
|---|---|---|---|
| Machine Readable NDC | 21 CFR 201.25 | Linear or 2D Matrix barcode | GTIN-14 / GS1-128 / DataMatrix |
| Human Readable Text | 21 CFR 201.57 | Product identifier printed in clear text | NDC, SN, EXP, LOT |
Parsed JSON Response Model
The edge microservice transforms input payloads into strongly-typed hierarchical JSON envelopes with sub-5ms latency:
{
"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
Yes, certain OTC medications and all prescription biologics are covered under 21 CFR 201.
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