The square on every medicine pack. GS1 DataMatrix, explained.
GS1 DataMatrix is a two-dimensional barcode, built on the ISO/IEC 16022 Data Matrix symbology, that encodes GS1 identifiers such as the GTIN, serial number, batch and expiry date. It is the 2D symbol used to serialize prescription medicines in the US under DSCSA and in the EU under the Falsified Medicines Directive.
- GS1 DATAMATRIX · CONTENTS (EXAMPLE)
- (01)GTIN, 14 digits
- (17)expiry, YYMMDD
- (10)batch or lot
- (21)serial number
- ISO/IEC 16022FNC1 first
Where it stands.
Each line names the source it was checked against.
- United States
- DSCSA requires a product identifier on each package of prescription drug: the NDC, a serial number, the lot and the expiry date, in human-readable form and in a 2D data carrier. Industry uses GS1 DataMatrix, with the NDC inside the GTIN. FD&C Act §581(14), §582
- European Union
- Since 9 February 2019 most prescription medicines in the EU carry a unique identifier in a Data Matrix code: product code, serial number, batch and expiry, plus a national reimbursement number where a country requires one, and an anti-tampering device. Delegated Reg. (EU) 2016/161
- NDC-12
- FDA's final rule of March 2026 moves every National Drug Code to a uniform 12-digit format, effective 7 March 2033, so every drug label is reissued once. GS1 Application Identifier (715) carries the US NDC. FDA final rule, March 2026; GS1
- UAE
- The UAE's Tatmeen platform asks for a GS1 DataMatrix with GTIN, serial number, batch and expiry on medicines, with aggregation and event reporting. Tatmeen; Al Tamimi & Co.
What a good DataMatrix needs.
FNC1 first
A GS1 DataMatrix starts with the FNC1 character, which tells the scanner the data is GS1 Application Identifiers rather than free text.
The right AIs
(01) GTIN, (17) expiry as YYMMDD, (10) batch or lot and (21) serial number, with variable-length fields separated so a scanner can split them.
Print quality
Symbols are graded against ISO/IEC 15415. A code that reads on the packing line but fails at a pharmacy counter is a dispensing problem.
Human-readable too
DSCSA and the EU rules both require the same data in human-readable form next to the symbol, where the pack allows.
Where the DataMatrix is required.
Medicines first: the rules that require the symbol, and what it can and cannot prove.
DSCSA
The US product identifier, package by package.
Read the guide →NDC-12NDC-12 transition
Effective 7 March 2033; labels by 6 March 2036.
Read the guide →AuthenticationNFC vs QR for pharma authentication
What the 2D code proves, and what it cannot.
Read the guide →Web addressGS1 Digital Link
When the 2D code should open a web page.
Read the guide →ManufacturersDSCSA for manufacturers
Serialization at the packing line.
Read the guide →RepackagersDSCSA for repackagers
New identifiers linked to the original ones.
Read the guide →How Aeroz builds on the code you print.
The code you already print
Aeroz reads the GS1 DataMatrix your packaging line already prints and binds it to the chip on the same pack.
A copied code can be flagged
A printed code can be photographed and reprinted. The chip answers each tap with a fresh response, so a copied DataMatrix on a fake pack can be flagged.
One relabel for NDC-12
If you are relabelling for NDC-12 before 2033, the same run can add the chip.
GS1 DataMatrix, answered.
What is a GS1 DataMatrix?
A GS1 DataMatrix is a square two-dimensional barcode that encodes GS1 Application Identifiers, such as the GTIN, expiry date, batch and serial number, using the ISO/IEC 16022 Data Matrix symbology with an FNC1 character first. It is the standard 2D symbol for serialized medicines and many medical devices.
What is the difference between a GS1 DataMatrix and a QR code?
A GS1 DataMatrix is compact, reads reliably on small and curved packs, and carries GS1 identifiers in the form pharmacy and hospital scanners already read; it is required on medicines in the US and the EU. A QR code holds more data and phones read it natively, so it is used for GS1 Digital Link web addresses on consumer goods.
Which Application Identifiers does DSCSA use?
For DSCSA, the GS1 DataMatrix on a drug package normally carries (01) the GTIN, which contains the NDC, (21) the serial number, (10) the lot number and (17) the expiration date. Together they form the DSCSA product identifier, which must also be printed in human-readable form.
Does a GS1 DataMatrix prove a medicine is genuine?
Not on its own. The DataMatrix carries a serial number that can be checked against the manufacturer's records, which catches invented serials. A counterfeiter who copies a real code can pass that check, which is why verification systems also look for duplicate scans and why some brands add a chip.
Sources: GS1 DataMatrix guideline · Delegated Regulation (EU) 2016/161 · FDA: Drug Supply Chain Security Act · FDA final rule on the 12-digit NDC, 91 FR 10749. Checked 24 October 2026. Not legal advice.
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- Serialization Caught Fake Ozempic in 2023. Here Is What It Can’t Catch.
- Fake Vials Carried QR Codes. They Did Not Scan.
More answers: Questions on standards, data carriers and NFC in the compliance FAQ
GS1 DataMatrix is the 2D barcode on serialized medicines in the US (DSCSA) and in the EU (since 9 February 2019). It carries the GTIN, serial number, batch and expiry date.
- Symbology
- ISO/IEC 16022
- Grading
- ISO/IEC 15415
- EU medicines
- since 9 Feb 2019
- NDC-12
- 7 Mar 2033