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FDA DSCSA & EU FMD Prescription Drug Serialization API

Deterministic edge engine for US Drug Supply Chain Security Act (DSCSA) 21 U.S.C. 360eee and EU Falsified Medicines Directive (2011/62/EU) compliance.

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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 Edge Parse' to test live on Global Edge Isolates..."
}
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Key Capabilities & Performance Architecture

Compliance Standards & Specs (6 Specifications)

Explore full structural breakdowns, checksum logic, and field schemas for every supported format.

API Endpoints & Request Signatures

Method Path Description
POST /api/v1/dscsa/validate-barcode Validate raw 2D DataMatrix GS1 barcode and extract 4 DSCSA elements
POST /api/v1/dscsa/ndc-to-gtin Convert 10-digit NDC to standard 14-digit GTIN with Modulo-10 checksum

Sample Response JSON Payload

All endpoints deliver strongly-typed envelopes with deterministic parsing and performance metrics.

HTTP 200 Response Payload
{
  "success": true,
  "data": {
    "valid": true,
    "gtin": "00301234567896",
    "serialNumber": "123456789012",
    "expirationDate": "2026-08-31",
    "lotNumber": "LOT99881",
    "ndc": "01234-567-89",
    "gtinCheckDigitValid": true,
    "status": "VERIFIED"
  },
  "meta": {
    "latency_ms": 1.62,
    "version": "1.0.0"
  }
}

Multi-Language Integration Code

Copy and paste ready-to-run snippets with your direct API credentials:

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

What are the 4 mandatory FDA DSCSA barcode elements?

Under DSCSA Section 582, prescription drug packages must carry a 2D DataMatrix barcode with: (1) GTIN-14 / National Drug Code (AI 01), (2) Serial Number up to 20 alphanumeric characters (AI 21), (3) Expiration Date in YYMMDD format (AI 17), and (4) Lot/Batch Number up to 20 characters (AI 10).

How does NDC to GTIN-14 conversion work?

The US FDA NDC comes in 10-digit formats (4-4-2, 5-3-2, or 5-4-2). To create a standard 14-digit GTIN, the NDC is zero-padded to an 11-digit HIPAA format, prepended with GS1 company prefix digits, and finalized with a calculated Modulo-10 check digit.

What is GS1 VRS (Verification Router Service)?

VRS is the interoperable protocol mandated for wholesalers and dispensers to query pharmaceutical manufacturers in real-time to verify saleable drug returns before restocking.