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.
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.
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).
| 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 |
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.
Parsed JSON Response Model
The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:
{
"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 --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"
}'
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);
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())
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
Yes, certain OTC medications and all prescription biologics are covered under 21 CFR 201.
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