Release 5 Ballot
Medication DefinitionThis page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B
| Biomedical Research and Regulation Work Group | Maturity Level: 2 | Trial Use | Security Category: Anonymous | Compartments: Not linked to any defined compartments |
An ingredient of a manufactured item or pharmaceutical product.
For an overview of this resource and others in the Medication Definition domain, also see the module page
A material used in the preparation of a medicinal/pharmaceutical product, within the context of a particular use or role.
An ingredient is part of a product, either alone or in combination with other ingredients. It is essentially a substance with the addition of the specific role it is playing in the product, or in preparation of the product which may include whether it is an active or inactive substance and what the strength is (the quantity of substance compared to the whole product). The ingredient is represented in the context of a given product, because its role and strength are a function of what it is used in/for. It is expected that the same substance used in a different role, or with a different strength, would be a different Ingredient resource instance. Resource instances may however be shared by very similar products (e.g. different pack sizes of the same "product").
Some other resources, such as Medication and Substance allow specifying a basic ingredient representation. When more detail is needed such as for manufacturing or regulatory use, use the Ingredient resource.
Structure
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Ingredient | TU | DomainResource | An ingredient of a manufactured item or pharmaceutical product + Rule: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
  identifier | Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
 status | ?!Σ | 1..1 | code | draft | active | retired | unknown PublicationStatus (Required) |
 for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | The product which this ingredient is a constituent part of |
| role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive IngredientRole (Example) |
| function | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent IngredientFunction (Example) |
| group | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink |
| allergenicIndicator | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen |
  manufacturer | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient |
 role | Σ | 0..1 | code | allowed | possible | actual IngredientManufacturerRole (Required) |
 manufacturer | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient |
 substance | Σ | 1..1 | BackboneElement | The substance that comprises this ingredient |
 code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance SNOMED CT Substance Codes (Example) |
| strength | Σ | 0..* | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
 presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |
| presentationRatio | Ratio | |||
| presentationRatioRange | RatioRange | |||
| presentationCodeableConcept | CodeableConcept | |||
| presentationQuantity | Quantity | |||
| textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
| concentration[x] | Σ | 0..1 | The strength per unitary volume (or mass) | |
| concentrationRatio | Ratio | |||
| concentrationRatioRange | RatioRange | |||
| concentrationCodeableConcept | CodeableConcept | |||
| concentrationQuantity | Quantity | |||
| textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
| basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) |
| measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance |
| country | Σ | 0..* | CodeableConcept | Where the strength range applies Country (Example) |
| referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance |
| substance | Σ | 0..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance SNOMED CT Substance Codes (Example) |
| strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |
| strengthRatio | Ratio | |||
| strengthRatioRange | RatioRange | |||
| strengthQuantity | Quantity | |||
| measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance |
| country | Σ | 0..* | CodeableConcept | Where the strength range applies Country (Example) |
| Documentation for this format | ||||
See the Extensions for this resource
UML Diagram (Legend)
XML Template
<Ingredient xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..1 Identifier An identifier or code by which the ingredient can be referenced --></identifier> <status value="[code]"/><!-- 1..1 draft | active | retired | unknown --> <for><!-- 0..* Reference(AdministrableProductDefinition| ManufacturedItemDefinition|MedicinalProductDefinition) The product which this ingredient is a constituent part of --></for> <role><!-- 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive --></role> <function><!-- 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent --></function> <group><!-- 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink --></group> <allergenicIndicator value="[boolean]"/><!-- 0..1 If the ingredient is a known or suspected allergen --> <manufacturer> <!-- 0..* An organization that manufactures this ingredient --> <role value="[code]"/><!-- 0..1 allowed | possible | actual --> <manufacturer><!-- 1..1 Reference(Organization) An organization that manufactures this ingredient --></manufacturer> </manufacturer> <substance> <!-- 1..1 The substance that comprises this ingredient --> <code><!-- 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance --></code> <strength> <!-- 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity --> <presentation[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The quantity of substance in the unit of presentation --></presentation[x]> <textPresentation value="[string]"/><!-- 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) --> <concentration[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The strength per unitary volume (or mass) --></concentration[x]> <textConcentration value="[string]"/><!-- 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) --> <basis><!-- 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) --></basis> <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance --> <country><!-- 0..* CodeableConcept Where the strength range applies --></country> <referenceStrength> <!-- 0..* Strength expressed in terms of a reference substance --> <substance><!-- 0..1 CodeableReference(SubstanceDefinition) Relevant reference substance --></substance> <strength[x]><!-- 1..1 Ratio|RatioRange|Quantity Strength expressed in terms of a reference substance --></strength[x]> <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance --> <country><!-- 0..* CodeableConcept Where the strength range applies --></country> </referenceStrength> </strength> </substance> </Ingredient>
JSON Template
{
"resourceType" : "Ingredient",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : { Identifier }, // An identifier or code by which the ingredient can be referenced
"status" : "<code>", // R! draft | active | retired | unknown
"for" : [{ Reference(AdministrableProductDefinition|
ManufacturedItemDefinition|MedicinalProductDefinition) }], // The product which this ingredient is a constituent part of
"role" : { CodeableConcept }, // R! Purpose of the ingredient within the product, e.g. active, inactive
"function" : [{ CodeableConcept }], // Precise action within the drug product, e.g. antioxidant, alkalizing agent
"group" : { CodeableConcept }, // A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
"allergenicIndicator" : <boolean>, // If the ingredient is a known or suspected allergen
"manufacturer" : [{ // An organization that manufactures this ingredient
"role" : "<code>", // allowed | possible | actual
"manufacturer" : { Reference(Organization) } // R! An organization that manufactures this ingredient
}],
"substance" : { // R! The substance that comprises this ingredient
"code" : { CodeableReference(SubstanceDefinition) }, // R! A code or full resource that represents the ingredient substance
"strength" : [{ // The quantity of substance, per presentation, or per volume or mass, and type of quantity
// presentation[x]: The quantity of substance in the unit of presentation. One of these 4:
"presentationRatio" : { Ratio },
"presentationRatioRange" : { RatioRange },
"presentationCodeableConcept" : { CodeableConcept },
"presentationQuantity" : { Quantity },
"textPresentation" : "<string>", // Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
// concentration[x]: The strength per unitary volume (or mass). One of these 4:
"concentrationRatio" : { Ratio },
"concentrationRatioRange" : { RatioRange },
"concentrationCodeableConcept" : { CodeableConcept },
"concentrationQuantity" : { Quantity },
"textConcentration" : "<string>", // Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
"basis" : { CodeableConcept }, // A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
"measurementPoint" : "<string>", // When strength is measured at a particular point or distance
"country" : [{ CodeableConcept }], // Where the strength range applies
"referenceStrength" : [{ // Strength expressed in terms of a reference substance
"substance" : { CodeableReference(SubstanceDefinition) }, // Relevant reference substance
// strength[x]: Strength expressed in terms of a reference substance. One of these 3:
"strengthRatio" : { Ratio },
"strengthRatioRange" : { RatioRange },
"strengthQuantity" : { Quantity },
"measurementPoint" : "<string>", // When strength is measured at a particular point or distance
"country" : [{ CodeableConcept }] // Where the strength range applies
}]
}]
}
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Structure
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Ingredient | TU | DomainResource | An ingredient of a manufactured item or pharmaceutical product + Rule: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
| identifier | Σ | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced |
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown PublicationStatus (Required) |
| for | Σ | 0..* | Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) | The product which this ingredient is a constituent part of |
| role | Σ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive IngredientRole (Example) |
| function | Σ | 0..* | CodeableConcept | Precise action within the drug product, e.g. antioxidant, alkalizing agent IngredientFunction (Example) |
| group | Σ | 0..1 | CodeableConcept | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink |
| allergenicIndicator | Σ | 0..1 | boolean | If the ingredient is a known or suspected allergen |
| manufacturer | Σ | 0..* | BackboneElement | An organization that manufactures this ingredient |
| role | Σ | 0..1 | code | allowed | possible | actual IngredientManufacturerRole (Required) |
| manufacturer | Σ | 1..1 | Reference(Organization) | An organization that manufactures this ingredient |
| substance | Σ | 1..1 | BackboneElement | The substance that comprises this ingredient |
| code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance SNOMED CT Substance Codes (Example) |
| strength | Σ | 0..* | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
| presentation[x] | Σ | 0..1 | The quantity of substance in the unit of presentation | |
| presentationRatio | Ratio | |||
| presentationRatioRange | RatioRange | |||
| presentationCodeableConcept | CodeableConcept | |||
| presentationQuantity | Quantity | |||
| textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
| concentration[x] | Σ | 0..1 | The strength per unitary volume (or mass) | |
| concentrationRatio | Ratio | |||
| concentrationRatioRange | RatioRange | |||
| concentrationCodeableConcept | CodeableConcept | |||
| concentrationQuantity | Quantity | |||
| textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
| basis | Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) |
| measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance |
| country | Σ | 0..* | CodeableConcept | Where the strength range applies Country (Example) |
| referenceStrength | Σ | 0..* | BackboneElement | Strength expressed in terms of a reference substance |
| substance | Σ | 0..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance SNOMED CT Substance Codes (Example) |
| strength[x] | Σ | 1..1 | Strength expressed in terms of a reference substance | |
| strengthRatio | Ratio | |||
| strengthRatioRange | RatioRange | |||
| strengthQuantity | Quantity | |||
| measurementPoint | Σ | 0..1 | string | When strength is measured at a particular point or distance |
| country | Σ | 0..* | CodeableConcept | Where the strength range applies Country (Example) |
| Documentation for this format | ||||
See the Extensions for this resource
XML Template
<Ingredient xmlns="http://hl7.org/fhir">
JSON Template
{
"resourceType" : "Ingredient",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : { Identifier }, // An identifier or code by which the ingredient can be referenced
"status" : "<code>", // R! draft | active | retired | unknown
"for" : [{ Reference(AdministrableProductDefinition|
ManufacturedItemDefinition|MedicinalProductDefinition) }], // The product which this ingredient is a constituent part of
"role" : { CodeableConcept }, // R! Purpose of the ingredient within the product, e.g. active, inactive
"function" : [{ CodeableConcept }], // Precise action within the drug product, e.g. antioxidant, alkalizing agent
"group" : { CodeableConcept }, // A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
"allergenicIndicator" : <boolean>, // If the ingredient is a known or suspected allergen
"manufacturer" : [{ // An organization that manufactures this ingredient
"role" : "<code>", // allowed | possible | actual
"manufacturer" : { Reference(Organization) } // R! An organization that manufactures this ingredient
}],
"substance" : { // R! The substance that comprises this ingredient
"code" : { CodeableReference(SubstanceDefinition) }, // R! A code or full resource that represents the ingredient substance
"strength" : [{ // The quantity of substance, per presentation, or per volume or mass, and type of quantity
// presentation[x]: The quantity of substance in the unit of presentation. One of these 4:
"presentationRatio" : { Ratio },
"presentationRatioRange" : { RatioRange },
"presentationCodeableConcept" : { CodeableConcept },
"presentationQuantity" : { Quantity },
"textPresentation" : "<string>", // Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
// concentration[x]: The strength per unitary volume (or mass). One of these 4:
"concentrationRatio" : { Ratio },
"concentrationRatioRange" : { RatioRange },
"concentrationCodeableConcept" : { CodeableConcept },
"concentrationQuantity" : { Quantity },
"textConcentration" : "<string>", // Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
"basis" : { CodeableConcept }, // A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
"measurementPoint" : "<string>", // When strength is measured at a particular point or distance
"country" : [{ CodeableConcept }], // Where the strength range applies
"referenceStrength" : [{ // Strength expressed in terms of a reference substance
"substance" : { CodeableReference(SubstanceDefinition) }, // Relevant reference substance
// strength[x]: Strength expressed in terms of a reference substance. One of these 3:
"strengthRatio" : { Ratio },
"strengthRatioRange" : { RatioRange },
"strengthQuantity" : { Quantity },
"measurementPoint" : "<string>", // When strength is measured at a particular point or distance
"country" : [{ CodeableConcept }] // Where the strength range applies
}]
}]
}
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
| Path | Definition | Type | Reference |
|---|---|---|---|
| Ingredient.status | The lifecycle status of an artifact. | Required | PublicationStatus |
| Ingredient.role | A classification of the ingredient identifying its purpose within the product. | Example | IngredientRole |
| Ingredient.function | A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive). | Example | IngredientFunction |
| Ingredient.manufacturer.role | The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role. | Required | IngredientManufacturerRole |
| Ingredient.substance.code | This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | Example | SNOMEDCTSubstanceCodes |
| Ingredient.substance.strength.country | This value set defines a base set of codes for countries. Note: The codes for countries are taken from ISO 3166 | Example | Country ValueSet |
| Ingredient.substance.strength.referenceStrength.substance | This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | Example | SNOMEDCTSubstanceCodes |
| Ingredient.substance.strength.referenceStrength.country | This value set defines a base set of codes for countries. Note: The codes for countries are taken from ISO 3166 | Example | Country ValueSet |
| UniqueKey | Level | Location | Description | Expression |
 ing-1 | Rule | (base) | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource | (Ingredient.allergenicIndicator.where(value='true').count() + Ingredient.substance.code.reference.count()) < 2 |
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
| Name | Type | Description | Expression | In Common |
| for | reference | The product which this ingredient is a constituent part of | Ingredient.for (AdministrableProductDefinition, ManufacturedItemDefinition, MedicinalProductDefinition) | |
| function | token | A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: Antioxidant, Alkalizing Agent | Ingredient.function | |
| identifier | token | An identifier or code by which the ingredient can be referenced | Ingredient.identifier | |
| manufacturer | reference | The organization that manufactures this ingredient | Ingredient.manufacturer | |
| role | token | A classification of the ingredient identifying its purpose within the product, e.g. active, inactive | Ingredient.role | |
| status | token | The status of this ingredient. Enables tracking the life-cycle of the content | Ingredient.status | |
| substance D | reference | Reference to a resource (by instance) | Ingredient.substance.code.reference | |
| substance-code D | token | Reference to a concept (by class) | Ingredient.substance.code.concept | |
| substance-definition D | reference | Reference to a resource (by instance) | Ingredient.substance.code.reference |
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Sat, Sep 10, 2022 05:04+1000.
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