PackagedProductDefinition
The commercial packaging of a pharmaceutical product: box, vial, kit, multi-level pack. The packaging grain of the ISO IDMP chain.
Purpose
PackagedProductDefinition describes the commercial presentation of a drug: units per box, inner packaging (blister, sachet), outer packaging (printed carton), kits combining multiple products. The resource drives unit-price calculation, barcode scanning, and per-batch manufacturer traceability.
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
identifier | Identifier[] | 0..* | Identifiers (GTIN, NDC, CIP). |
name | string | 0..1 | Packaging name. |
type | CodeableConcept | 0..1 | Pack type. |
packageFor | Reference(MedicinalProductDefinition)[] | 0..* | Packaged product. |
status | CodeableConcept | 0..1 | Status. |
containedItemQuantity | Quantity[] | 0..* | Total quantity inside the pack. |
description | markdown | 0..1 | Description. |
legalStatusOfSupply | BackboneElement[] | 0..* | Legal status (Rx, OTC). |
marketingStatus | MarketingStatus[] | 0..* | Marketing status. |
characteristic | CodeableConcept[] | 0..* | Characteristics (colour, material). |
packaging | BackboneElement | 0..1 | Recursive composition (pack → blister → tablets). |
JSON example
{
"resourceType": "PackagedProductDefinition",
"id": "example-aspirin-box-20",
"identifier": [{
"system": "https://www.gs1.org/gtin",
"value": "03400938153317"
}],
"name": "Aspirine 300mg, boîte de 20 comprimés",
"type": {
"coding": [{
"system": "http://hl7.org/fhir/packagedproductdefinition-package-type",
"code": "Box"
}]
},
"packageFor": [{
"reference": "MedicinalProductDefinition/aspirin-300"
}],
"containedItemQuantity": [{
"value": 20,
"unit": "tablet"
}],
"packaging": {
"type": {
"coding": [{
"system": "http://standardterms.edqm.eu",
"code": "30009000",
"display": "Box"
}]
},
"quantity": 1
}
}Common pitfalls
- containedItemQuantity vs packaging.quantity: containedItemQuantity = number of final units, packaging.quantity = number of packs at this level.
- No GTIN: hampers GS1 traceability.
- Missing legalStatusOfSupply: cannot tell whether the product is Rx-only.
Related resources
- medicinalproductdefinition — medicinal product.
- administrableproductdefinition — administrable form.
- manufactureditemdefinition — manufactured item.
- regulatedauthorization — MA.