Published: Jul 16, 2025 by Kurt Wolf
When working with GTIN-14 values in pharmaceutical labeling or supply chain traceability, one of the most overlooked yet critical components is the Packaging Indicator—the first digit in the 14-digit GTIN. This digit helps differentiate between packaging levels in a product’s hierarchy and ensures that each packaging configuration can be uniquely identified and traced.
What Is the Packaging Indicator
The packaging indicator, also known as the indicator digit, is the first digit of a GTIN-14. It does not change the identity of the product itself (which is determined by the NDC portion) but instead identifies the level of packaging.
This is especially important in pharmaceutical environments where unit-of-use items, cartons, cases, and pallets must each carry a unique GTIN for DSCSA compliance, RFID tagging, inventory management, and serialization.
Common Packaging Indicator Values
| Indicator Digit | Packaging Level | Use Case Example |
|---|---|---|
0 |
Not valid for GTIN-14 | Used only to convert GTIN-12/GTIN-8 internally |
1 |
Base level (unit of use) | Single vial, syringe, or blister pack |
2 |
Inner pack | Box of 5 vials |
3 |
Carton or mid-level package | Carton of multiple inner packs |
4 to 8 |
Higher-level packaging | Master case, outer case, pallet |
9 |
Variable measure trade item | Items sold by weight, volume, or length |
Indicator
0is not used for newly assigned GTIN-14s. It is reserved for internal expansion of shorter GTINs.
Selecting the Right Packaging Indicator
Selecting the correct packaging indicator is not arbitrary. It should reflect the item’s position in the packaging hierarchy:
- Use
1for the lowest-level saleable unit. - Assign
2,3,4, etc. for each higher-level packaging tier. - All levels must share the same product identifier (such as the NDC-11) but differ in the indicator digit and check digit.
- Ensure consistency between packaging documentation and labeling systems.
If multiple units contain the same product but are packaged differently, each package type must be assigned a unique GTIN-14 using a different indicator digit.
Example: Packaging Hierarchy for a Single NDC
| Packaging Description | Indicator | GTIN-14 |
|---|---|---|
| Single vial | 1 |
1012345678903 |
| Box of 10 vials | 3 |
3012345678906 |
| Master case (10 boxes) | 5 |
5012345678900 |
All three examples use the same base NDC-11: 01234567890, but differ by packaging indicator and check digit.
Why It Matters
The packaging indicator is essential for:
- Regulatory compliance, including DSCSA and global UDI systems
- Serialization and track-and-trace solutions
- RFID or barcode labeling for inventory control
- Avoiding duplication or confusion between different package types
Systems that ignore or misassign packaging indicators risk mismatched scans, rejected shipments, and failed compliance audits.
Best Practices
- Define your packaging hierarchy early in the product lifecycle
- Document indicator assignments clearly and consistently
- Validate with your GS1 company prefix and check digit calculation
- Coordinate with manufacturing, logistics, and IT to ensure system-wide consistency
Conclusion
The packaging indicator in a GTIN-14 is a simple concept with powerful implications. By thoughtfully assigning and maintaining it, pharmaceutical manufacturers and supply chain partners can ensure accurate tracking, clear differentiation between package levels, and full regulatory compliance.