US FDA DSCSA & EU FMD Prescription Drug Serialization & Verification API
Sub-5ms FDA 21 USC § 360eee 4-Element & EU FMD 2011/62/EU 2D DataMatrix Barcode Parser & EPCIS SGTIN Engine
The US FDA DSCSA & EU FMD Prescription Drug Serialization & Verification API delivers ultra-fast, deterministic validation and parsing of serialized pharmaceutical packaging identifiers across US FDA DSCSA (21 U.S.C. § 360eee) and EU Falsified Medicines Directive (2011/62/EU & Delegated Regulation 2016/161) standards.
Engineered for digital health providers, hospital pharmacy systems, 3PL pharmaceutical distributors, and ERP software: parse raw 2D DataMatrix scans, verify the mandatory DSCSA 4 elements (GTIN, Serial Number, Lot Number, Expiration Date), bidirectionally translate 10-digit/11-digit NDCs to GTIN-14, test serial entropy against EU standards, generate EPCIS SGTIN URNs, and evaluate GS1 Verification Router Service (VRS) requests.
All verification executes entirely in pure compute across Cloudflare Workers edge nodes with sub-5ms latency, zero external subrequests, and 100% deterministic reliability.
Features
- Full US FDA DSCSA 4-element compliance checklist (GTIN-14, Serial, Lot, Expiration Date)
- EU FMD 2011/62/EU Unique Identifier validation with Article 6 serial randomness & entropy scoring
- Bidirectional 10-digit (4-4-2, 5-3-2, 5-4-1) & 11-digit HIPAA NDC <-> GTIN-14 translation with Modulo-10 calculation
- Multi-format barcode scanner: handles raw ASCII 29 GS, [FNC1], human-readable parentheses, and GS1 Digital Link URIs
- GS1 General Specifications day '00' expiration date support (last calendar day of month rollover)
- EPCIS 1.2 / 2.0 SGTIN URN constructor with full GS1 Company Prefix partition table support
- GS1 DSCSA Verification Router Service (VRS) query evaluator with standard response envelopes
- Pure compute edge architecture with sub-5ms response times and zero database latency
Endpoints
| Method | Path | Description | Example |
|---|---|---|---|
POST | /api/v1/dscsa/verify | Verify US FDA DSCSA 4-element prescription drug serialization compliance | /api/v1/dscsa/verify |
POST | /api/v1/dscsa/parse | Parse raw GS1 DataMatrix barcode string into structured DSCSA identifiers | /api/v1/dscsa/parse |
POST | /api/v1/fmd/verify | Verify EU FMD 2011/62/EU unique identifier, national codes & serial entropy | /api/v1/fmd/verify |
POST | /api/v1/fmd/parse | Parse EU FMD DataMatrix barcode into EMVS-ready payload | /api/v1/fmd/parse |
POST | /api/v1/ndc/convert | Bidirectional NDC (10-digit / 11-digit HIPAA) and GTIN-14 converter | /api/v1/ndc/convert |
POST | /api/v1/epcis/sgtin | Generate EPCIS SGTIN URN and GS1 Digital Link URI from GTIN and Serial | /api/v1/epcis/sgtin |
POST | /api/v1/dscsa/vrs | Evaluate GS1 US Verification Router Service (VRS) lightweight query | /api/v1/dscsa/vrs |
GET | /health | Service health check | /health |
FAQ
What are the 4 mandatory product identifiers required by US FDA DSCSA?
Under US Federal Law (21 U.S. Code § 360eee), prescription drug packages must carry a 2D DataMatrix barcode encoding: (1) National Drug Code embedded in GTIN-14 (AI 01), (2) unique Serial Number up to 20 alphanumeric characters (AI 21), (3) Lot/Batch Number (AI 10), and (4) Expiration Date in YYMMDD format (AI 17).
How does the API handle GS1 expiration dates with day '00'?
Per GS1 General Specifications Section 7.12, when day digits in AI (17) are '00', it specifies that the product expires on the last calendar day of the given month. Our date parser automatically computes the exact last day (including leap year Feb 29 calculations) and outputs standard ISO-8601 dates.
What is the EU FMD serial number entropy requirement?
Article 6 of Commission Delegated Regulation (EU) 2016/161 mandates that serial numbers generated for medicinal products must be randomized with a guessing probability of less than 1 in 10,000. Our API computes information entropy in bits to verify compliance with this anti-counterfeiting safeguard.
How does NDC to GTIN-14 conversion work?
The API normalizes 10-digit NDCs (4-4-2, 5-3-2, 5-4-1 formats) into standard 11-digit HIPAA format (5-4-2), prepends the GS1 US Healthcare prefix '03' with indicator digit '0', and calculates the Modulo-10 check digit using arithmetic fold to produce the 14-digit GTIN.