BatchFormulaBundle
type: Bundle
node role: treeRoot
id:
  v: BatchFormulaBundle
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32
identifier:
  system:
    v: urn:ietf:rfc:3986
type:
  v: document
timestamp:
  v: 2024-07-01T12:34:56.789Z

urn:…
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32
text:
  status:
    v: generated
  div: Generated Narrative: Composition 0003c00b-bfc2-4775-8b1c-9f99d5cf1f39 Profile: eCTD Batch Formula identifier: BatchFormulaComposition status: Final type: m3.2.p.3.2 batch formula date: 2024-07-01 12:34:56+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: Batch formula example
identifier:
  value:
    v: BatchFormulaComposition
status:
  v: final
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
    code:
      v: ich_3.2.p.3.2
    display:
      v: m3.2.p.3.2 batch formula
date:
  v: 2024-07-01T12:34:56.789Z
title:
  v: Batch formula example
section:
  title:
    v: Batch Formula
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
      code:
        v: ich_3.2.p.3.2
      display:
        v: m3.2.p.3.2 batch formula

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a Profile: Basic Organization identifier: DUNS/143265222 name: Wunderwerke Contacts - Address * Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265222
name:
  v: Wunderwerke
contact:
  address:
    type:
      v: postal
    text:
      v: Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
    line:
      v: 123 Scenic Road
    city:
      v: Bridgeport
    state:
      v: CT
    postal code:
      v: 65478
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization e875ef93-a730-4c44-bead-53663ae7f501 Profile: Basic Organization identifier: DUNS/147275722, FEI/6981397 name: East-West Manufacturing Contacts - Address * East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 147275722
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134004
      display:
        v: FEI
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 6981397
name:
  v: East-West Manufacturing
contact:
  address:
    type:
      v: postal
    text:
      v: East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States
    line:
      v: 100 Stillwater Avenue
    line:
      v: Building #2
    city:
      v: Bangor
    state:
      v: ME
    postal code:
      v: 04401
    country:
      v: USA

urn:…
type: MedicinalProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product
text:
  status:
    v: generated
  div: Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c Profile: Batch Formula Drug Product Identification identifier: Oxazepam-Propranolol-BatchFormula-Identification combinedPharmaceuticalDoseForm: LIQUID route: ORAL comprisedOf: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 name productName: ATOMOXETINE HYDROCHLORIDE 1mg type: Nonproprietary Name part part: ATOMOXETINE HYDROCHLORIDE type: scientific name part part: 1mg type: ATOMOXETINE HYDROCHLORIDE
identifier:
  value:
    v: Oxazepam-Propranolol-BatchFormula-Identification
combined pharmaceutical dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42953
    display:
      v: LIQUID
route:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C38288
    display:
      v: ORAL
name:
  product name:
    v: ATOMOXETINE HYDROCHLORIDE 1mg
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96971
      display:
        v: Nonproprietary Name
  part:
    part:
      v: ATOMOXETINE HYDROCHLORIDE
  part:
    part:
      v: 1mg
    type:
      text:
        v: ATOMOXETINE HYDROCHLORIDE

urn:…
type: ManufacturedItemDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula
text:
  status:
    v: extensions
  div: Generated Narrative: ManufacturedItemDefinition 249ef22b-d521-4304-a388-6b9035f97b22 Profile: Drug Product Batch Formula identifier: Oxazepam-Propranolol-BatchFormula status: Active name: ATOMOXETINE HYDROCHLORIDE 1mg manufacturedDoseForm: Liquid manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 property type: Batch Quantity value: 50 liter (Details: UCUM codeL = 'L') property type: Batch Utilization value: Commercial property type: Batch Formula Additional Information value: Makes 50 Litres of product, accounting for losses from evaporation and spillage component type: Solution amount: 53.2 kilogram (Details: UCUM codekg = 'kg'), 100 percent (Details: UCUM code% = '%') constituent Product Batch Strength Textual Extension: 5% atomexetine hydrochloride solution amount: 25.42 gram (Details: UCUM codeg = 'g'), 0.0477 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 20.5 gram (Details: UCUM codeg = 'g'), 0.0385 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 5 gram (Details: UCUM codeg = 'g'), 0.0094 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 2.27 kilogram (Details: UCUM codekg = 'kg'), 4.2652 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 150 gram (Details: UCUM codeg = 'g'), 0.2818 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a24…
identifier:
  value:
    v: Oxazepam-Propranolol-BatchFormula
status:
  v: active
name:
  v: ATOMOXETINE HYDROCHLORIDE 1mg
manufactured dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C45298
    display:
      v: Liquid
property:
  type:
    text:
      v: Batch Quantity
  value: Quantity
    value:
      v: 50
    unit:
      v: liter
    system:
      v: http://unitsofmeasure.org
    code:
      v: L
property:
  type:
    text:
      v: Batch Utilization
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C133990
      display:
        v: Commercial
property:
  type:
    text:
      v: Batch Formula Additional Information
  value: markdown
    v: Makes 50 Litres of product, accounting for losses from evaporation and spillage
component:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C42986
      display:
        v: Solution
  amount:
    value:
      v: 53.2
    unit:
      v: kilogram
    system:
      v: http://unitsofmeasure.org
    code:
      v: kg
  amount:
    value:
      v: 100
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  constituent:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
      value: string
        v: 5% atomexetine hydrochloride solution
    amount:
      value:
        v: 25.42
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 0.0477
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
  constituent:
    amount:
      value:
        v: 20.5
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 0.0385
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
  constituent:
    amount:
      value:
        v: 5
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 0.0094
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
  constituent:
    amount:
      value:
        v: 2.27
      unit:
        v: kilogram
      system:
        v: http://unitsofmeasure.org
      code:
        v: kg
    amount:
      value:
        v: 4.2652
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
  constituent:
    amount:
      value:
        v: 150
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 0.2818
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
  constituent:
    amount:
      value:
        v: 50.75
      unit:
        v: kilogram
      system:
        v: http://unitsofmeasure.org
      code:
        v: kg
    amount:
      value:
        v: 95.3572
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 1c1a2a23-1fd7-4487-9682-49877f9f9f77 Profile: Drug Product Batch Formula Ingredient identifier: AtomexetineHydrochlorideBFIngredient status: Active role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 25.42 gram (Details: UCUM codeg = 'g') strength concentration: 0.0477 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: AtomexetineHydrochlorideBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C82533
    display:
      v: Active Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 25.42
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 0.0477
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058 Profile: Drug Substance Handle classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 Codes - Code * 57WVB6I2W0 Names - Name Type Preferred * ATOMOXETINE HYDROCHLORIDE GSRS Preferred Term true
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 57WVB6I2W0
name:
  name:
    v: ATOMOXETINE HYDROCHLORIDE
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2 Profile: Drug Product Batch Formula Ingredient identifier: GlacialAceticAcidBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 20.5 gram (Details: UCUM codeg = 'g') strength concentration: 0.0385 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: GlacialAceticAcidBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 20.5
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 0.0385
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 45942749-64db-4f91-88c3-51adb680fed1 Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * Q40Q9N063P Names - Name Type Preferred * ACETIC ACID GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: Q40Q9N063P
name:
  name:
    v: ACETIC ACID
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 45eb4f05-83d9-4819-bb60-96c7c5ce2b76 Profile: Drug Product Batch Formula Ingredient identifier: AnhydrousSodiumAcetateBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 5 gram (Details: UCUM codeg = 'g') strength concentration: 0.0094 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: AnhydrousSodiumAcetateBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 5
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 0.0094
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 07c598ee-3dcf-45b7-b4e5-b24812c22aff Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * NVG71ZZ7P0 Names - Name Type Preferred * SODIUM ACETATE ANHYDROUS GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: NVG71ZZ7P0
name:
  name:
    v: SODIUM ACETATE ANHYDROUS
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552 Profile: Drug Product Batch Formula Ingredient identifier: MannitolBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 2.27 kilogram (Details: UCUM codekg = 'kg') strength concentration: 4.2652 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: MannitolBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 2.27
      unit:
        v: kilogram
      system:
        v: http://unitsofmeasure.org
      code:
        v: kg
  strength:
    concentration: Quantity
      value:
        v: 4.2652
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * 3OWL53L36A Names - Name Type Preferred * MANNITOL GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 3OWL53L36A
name:
  name:
    v: MANNITOL
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 44fad9fd-826a-4f0c-9f25-e0a78d1c4269 Profile: Drug Product Batch Formula Ingredient identifier: MetacresolBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 150 gram (Details: UCUM codeg = 'g') strength concentration: 0.2818 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: MetacresolBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 150
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 0.2818
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition c75df5fb-e962-43a6-9dd3-c6682da10a7e Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * GGO4Y809LO Names - Name Type Preferred * METACRESOL GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: GGO4Y809LO
name:
  name:
    v: METACRESOL
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient d0574580-7694-4a36-8a27-5bdbccfc5557 Profile: Drug Product Batch Formula Ingredient identifier: WaterBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 50.75 kilogram (Details: UCUM codekg = 'kg') strength concentration: 95.3572 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: WaterBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 50.75
      unit:
        v: kilogram
      system:
        v: http://unitsofmeasure.org
      code:
        v: kg
  strength:
    concentration: Quantity
      value:
        v: 95.3572
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition c4e5b7c6-2e52-48e3-813b-d227cf29329b Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * 059QF0KO0R Names - Name Type Preferred * WATER GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 059QF0KO0R
name:
  name:
    v: WATER
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

v: SCI

v: STR

type:
  text:
    v: Product Part Identifier
value: CodeableConcept
  text:
    v: solution