Ingredient
A substance present in a pharmaceutical product with quantity, function (active, excipient) and role. Building block of the ISO IDMP model.
Purpose
Ingredient decomposes a MedicinalProductDefinition's composition into individual substances: active substance (with concentration), excipient, preservative, colourant. The resource is sized to carry the information required for regulatory submissions (FDA SPL, EMA SPOR) and feeds the structured list of components in the SmPC.
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
identifier | Identifier | 0..1 | Unique identifier. |
status | code | 1..1 | `draft`, `active`, `retired`, `unknown`. |
for | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)[] | 0..* | Product this is an ingredient of. |
role | CodeableConcept | 1..1 | Role (active, excipient, preservative). |
function | CodeableConcept[] | 0..* | Technical function. |
allergenicIndicator | boolean | 0..1 | Known allergen. |
manufacturer | BackboneElement[] | 0..* | Authorised manufacturers. |
substance | BackboneElement | 1..1 | Substance + presented strength (numerator/denominator). |
JSON example
{
"resourceType": "Ingredient",
"id": "example-aspirin-active",
"status": "active",
"for": [{
"reference": "AdministrableProductDefinition/example-tablet"
}],
"role": {
"coding": [{
"system": "http://hl7.org/fhir/ingredient-role",
"code": "active",
"display": "Active Ingredient"
}]
},
"allergenicIndicator": false,
"substance": {
"code": {
"concept": {
"coding": [{
"system": "http://snomed.info/sct",
"code": "387458008",
"display": "Aspirin (substance)"
}]
}
},
"strength": [{
"presentationRatio": {
"numerator": {
"value": 300,
"unit": "mg"
},
"denominator": {
"value": 1,
"unit": "tablet"
}
}
}]
}
}Common pitfalls
- presentationRatio vs concentrationRatio: presentation = per unit dose, concentration = per mL or g of product.
- allergenicIndicator left blank for high-risk excipients (latex, wheat): impact on pharmacovigilance.
- No reference to Substance or substance.code.concept: floating ingredient.
Related resources
- administrableproductdefinition — administrable form.
- medicinalproductdefinition — medicinal product.
- substancedefinition — chemical substance.
- allergyintolerance — patient allergy.