# 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.

- **Canonical URL:** https://stanzaapi.com/tools/pharma-dscsa/compliance/fda-21-cfr-201-barcode
- **Governing Standard:** 21 U.S. Code § 360eee / GS1 EPCIS (U.S. Food & Drug Administration (FDA) DSCSA)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

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

## Specification Matrix
| 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 |

## Standard JSON Response Model
```json
{
  "regulation": "21 CFR 201.25",
  "complianceStatus": "PASS",
  "ndc": "01234-567-89",
  "gtin": "00301234567896",
  "machineReadableValid": true
}
```

## Frequently Asked Questions & Edge Cases
### Q: Does 21 CFR 201 apply to over-the-counter (OTC) drugs?
**A:** Yes, certain OTC medications and all prescription biologics are covered under 21 CFR 201.