{ "description": "Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. Some but not all are defined in NCIt. When all codes are in NCIt, they will migrate to the HL7 Terminology (THO). Note: Codes that exist in CNIt at time of ballot begin with 'C'.", "_filename": "CodeSystem-cmc-ncit-dummy.json", "package_name": "hl7.fhir.us.pq-cmc-fda", "date": "2024-04-08T17:51:06+00:00", "publisher": "HL7 International / Biomedical Research and Regulation", "jurisdiction": [ { "coding": [ { "code": "US", "system": "urn:iso:std:iso:3166", "display": "United States of America" } ] } ], "content": "complete", "name": "NCItDummy", "copyright": "PQ-CMC-FDA Temporary Codes are either in the current NCIt or are in the process of being included in NCI. When all codes are in NCIt, they will migrate to the HL7 Terminology (THO). License Note\t\nUnless otherwise indicated, all text within NCI products is free of copyright and may be reused without our permission. Credit the National Cancer Institute as the source.", "type": null, "experimental": "false", "resourceType": "CodeSystem", "title": "PQ-CMC-FDA Temporary Codes", "package_version": "1.0.0-ballot", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" } ], "status": "active", "id": "d590dcc1-9f92-4c33-8933-08956a6f2096", "kind": null, "count": 709, "url": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "identifier": [ { "value": "urn:oid:2.16.840.1.113883.4.642.40.36.16.1", "system": "urn:ietf:rfc:3986" } ], "concept": [ { "code": "batchsize", "display": "Batch Quantity" }, { "code": "batchinfo", "display": "Batch Formula Additional Information" }, { "code": "BatchUtil", "display": "Batch Utilization" }, { "code": "info", "display": "Product Part Additional Information" }, { "code": "CC201", "display": "Accelerated" }, { "code": "CC202", "display": "Intermediate" }, { "code": "CC203", "display": "Long term" }, { "code": "C203896", "display": "Blend" }, { "code": "C42890", "display": "Bead" }, { "code": "C203897", "display": "Capsule Shell" }, { "code": "C25450", "display": "Coating" }, { "code": "C202489", "display": "Dispersion" }, { "code": "C42938", "display": "Granules" }, { "code": "C66831", "display": "Layer" }, { "code": "C203898", "display": "Minitablets" }, { "code": "C42986", "display": "Solution" }, { "code": "C42998", "display": "Tablet" }, { "code": "C203881", "display": "Active core/granulate" }, { "code": "C203882", "display": "Extragranular" }, { "code": "C203883", "display": "Intragranular" }, { "code": "C42730", "display": "Delayed-Release Profile" }, { "code": "C42713", "display": "Extended-Release Profile" }, { "code": "C42669", "display": "Immediate Release Profile" }, { "code": "C203359", "display": "Matrix" }, { "code": "C203360", "display": "Osmotic Pump" }, { "code": "C203361", "display": "Reservoir" }, { "code": "C203884", "display": "Appearance/Identification" }, { "code": "C203885", "display": "Consumption Enhancement" }, { "code": "C203887", "display": "Delayed Release" }, { "code": "C203888", "display": "Drug Layering" }, { "code": "C203889", "display": "Extended Release" }, { "code": "C203890", "display": "Irritant Suppression" }, { "code": "C203886", "display": "Content Isolation" }, { "code": "C203891", "display": "Odor Masking" }, { "code": "C203892", "display": "Protective" }, { "code": "C203893", "display": "Seal" }, { "code": "C203894", "display": "Site of Action" }, { "code": "C203895", "display": "Taste Masking" }, { "code": "C203348", "display": "Hard Gelatin Capsule Shell" }, { "code": "C203349", "display": "Hard HPMC Capsule Shell" }, { "code": "C203351", "display": "Hard PVA Capsule Shell" }, { "code": "C203350", "display": "Hard Pullulan Capsule Shell" }, { "code": "C203352", "display": "Hard Starch Capsule Shell" }, { "code": "C203353", "display": "Soft Gelatin Capsule Shell" }, { "code": "C71898", "display": "Brand" }, { "code": "C97054", "display": "Generic Name" }, { "code": "C203355", "display": "GSRS Preferred Term" }, { "code": "C203357", "display": "Systematic Name" }, { "code": "C203358", "display": "USP-NF Established Name" }, { "code": "C54682", "display": "CAS Number" }, { "code": "C142585", "display": "INN" }, { "code": "C96973", "display": "USAN" }, { "code": "C203356", "display": "IUPAC Name" }, { "code": "C95517", "display": "ISBT-128 DIN" }, { "code": "C203354", "display": "Company ID/Code" }, { "code": "C115123", "display": "Abbreviated New Animal Drug Application" }, { "code": "C73113", "display": "Abbreviated New Drug Application" }, { "code": "C96089", "display": "Annual Report" }, { "code": "C96094", "display": "Supplement to an Approved Application" }, { "code": "C71778", "display": "Biologics License Application" }, { "code": "C70877", "display": "Master File" }, { "code": "C115122", "display": "Generic Investigational New Animal Drug File" }, { "code": "C80440", "display": "Humanitarian Device Exemption (HDE)" }, { "code": "C82667", "display": "Investigational Device Exemption" }, { "code": "C96091", "display": "Investigational New Animal Drug File" }, { "code": "C96090", "display": "Investigational New Drug Application" }, { "code": "C96092", "display": "New Active Ingredient" }, { "code": "C72901", "display": "New Animal Drug Application" }, { "code": "C72899", "display": "New Drug Application" }, { "code": "C70880", "display": "Premarket Approval" }, { "code": "C80442", "display": "Premarket Notification 510(K)" }, { "code": "C96154", "display": "Ambient Delayed Testing" }, { "code": "C96151", "display": "Delayed Testing" }, { "code": "C96153", "display": "Frozen Delayed Testing" }, { "code": "C96150", "display": "Immediate Testing" }, { "code": "C96155", "display": "Refrigerated Delayed Testing" }, { "code": "C134028", "display": "Complex" }, { "code": "C134027", "display": "Cycled-Simple" }, { "code": "C96087", "display": "Photostability" }, { "code": "C134026", "display": "Standard" }, { "code": "C185182", "display": "Approved" }, { "code": "C48660", "display": "Not Applicable" }, { "code": "C185188", "display": "Proposed" }, { "code": "C185186", "display": "Adequate" }, { "code": "OvrRelsProf", "display": "Product Overall Release Profile" }, { "code": "OvrRelsMech", "display": "Product Overall Release Mechanism" }, { "code": "CoatInd", "display": "Coating Indicator" }, { "code": "TabLayCnt", "display": "Tablet Layer Count" }, { "code": "BeaTypCnt", "display": "Tablet Bead Type Count" }, { "code": "CapConCnt", "display": "Capsule Constituent Count" }, { "code": "CapClass", "display": "Capsule Classification Category" }, { "code": "Schematic", "display": "Product Schematic" }, { "code": "WgtTyp", "display": "Product Weight Type" }, { "code": "TotWgtNum", "display": "Product Total Weight Numeric Numerator" }, { "code": "TotWgtDen", "display": "Product Total Weight Numeric Denominator" }, { "code": "TotWgtTxt", "display": "Total Weight Textual" }, { "code": "TotWgtOper", "display": "Total Weight Operator" }, { "code": "PPiD", "display": "Product Part Identifier" }, { "code": "PPiDref", "display": "Product Part Identifier Reference" }, { "code": "RelsProf", "display": "Product Part Release Profile" }, { "code": "RelsMech", "display": "Product Part Release Mechanism" }, { "code": "CoatPurpose", "display": "Coating Product Part Purpose" }, { "code": "Color", "display": "Product Part Color Description" }, { "code": "ContPercent", "display": "Product Part Content Percent" }, { "code": "AddInfo", "display": "Product Part Additional Information" }, { "code": "StrnType", "display": "Strength Type (for API)" }, { "code": "AmtOper", "display": "Product Part Ingredient Amount Operator" }, { "code": "AmtText", "display": "Product Part Ingredient Amount Textual" }, { "code": "QualStd", "display": "Quality Standard" }, { "code": "C133994", "display": "Bioequivalence" }, { "code": "C133992", "display": "Clinical" }, { "code": "C133990", "display": "Commercial" }, { "code": "C133991", "display": "Development" }, { "code": "C133993", "display": "Validation" }, { "code": "C185328", "display": "Stability Study" }, { "code": "C16275", "display": "Calculated" }, { "code": "C133995", "display": "Experimental" }, { "code": "C54683", "display": "InChI File (small molecule)" }, { "code": "C133997", "display": "mmCIF (large molecules)" }, { "code": "C133910", "display": "MOLFILE" }, { "code": "C49039", "display": "PDB" }, { "code": "C133996", "display": "SDF" }, { "code": "C54684", "display": "SMILES" }, { "code": "C85435", "display": "SVG" }, { "code": "C96113", "display": "Child-resistant, Metal" }, { "code": "C96114", "display": "Child-resistant, Plastic" }, { "code": "C96115", "display": "Continuous Thread, Metal" }, { "code": "C96116", "display": "Continuous Thread, Plastic" }, { "code": "C96117", "display": "Tamper-evident, Metal" }, { "code": "C96118", "display": "Tamper-evident, Plastic" }, { "code": "C96119", "display": "Vacuum, Metal" }, { "code": "C96120", "display": "Tamper-evident, Composite" }, { "code": "C96121", "display": "Vacuum, Plastic" }, { "code": "C96122", "display": "Vacuum, Composite" }, { "code": "C96123", "display": "Press-on/twist-off, Metal" }, { "code": "C96124", "display": "Press-on, Composite" }, { "code": "C96125", "display": "Crown, Metal" }, { "code": "C96126", "display": "Lug, Metal" }, { "code": "C96127", "display": "Roll-on, Metal" }, { "code": "C96128", "display": "Flip-Top (Dispensing), Plastic" }, { "code": "C96129", "display": "Hinged (Dispensing), Plastic" }, { "code": "C96130", "display": "Linerless, Plastic" }, { "code": "C96131", "display": "Pump (Dispensing), Plastic" }, { "code": "C96132", "display": "Push-pull (Dispensing), Plastic" }, { "code": "C96133", "display": "Snap-on Cap, Plastic" }, { "code": "C96134", "display": "Snip-tip (Dispensing), Plastic" }, { "code": "C96135", "display": "Toggle-swing (Dispensing), Plastic" }, { "code": "C96136", "display": "Trigger Sprayer (Dispensing), Plastic" }, { "code": "C96137", "display": "Twist Open/Close (Dispensing), Plastic" }, { "code": "C96138", "display": "Valved (Dispensing), Plastic" }, { "code": "C96139", "display": "Stopper" }, { "code": "C96140", "display": "Tie" }, { "code": "C80262", "display": "Conforms" }, { "code": "C133998", "display": "Does not conform" }, { "code": "C25241", "display": "Horizontal" }, { "code": "C133999", "display": "Inverted" }, { "code": "C86043", "display": "Upright" }, { "code": "C133915", "display": "Valve-down" }, { "code": "C133914", "display": "Valve-up" }, { "code": "C43165", "display": "AMPULE" }, { "code": "C43166", "display": "APPLICATOR" }, { "code": "C43167", "display": "BAG" }, { "code": "C43168", "display": "BLISTER PACK" }, { "code": "C43169", "display": "BOTTLE" }, { "code": "C43170", "display": "BOTTLE, DISPENSING" }, { "code": "C43171", "display": "BOTTLE, DROPPER" }, { "code": "C43172", "display": "BOTTLE, GLASS" }, { "code": "C43173", "display": "BOTTLE, PLASTIC" }, { "code": "C43174", "display": "BOTTLE, PUMP" }, { "code": "C43175", "display": "BOTTLE, SPRAY" }, { "code": "C43176", "display": "BOTTLE, UNIT-DOSE" }, { "code": "C43177", "display": "BOTTLE, WITH APPLICATOR" }, { "code": "C43178", "display": "BOX" }, { "code": "C43179", "display": "BOX, UNIT-DOSE" }, { "code": "C43180", "display": "CAN" }, { "code": "C43181", "display": "CANISTER" }, { "code": "C96143", "display": "Canisters, lined" }, { "code": "C92708", "display": "CAPSULE" }, { "code": "C43182", "display": "CARTON" }, { "code": "C43183", "display": "CARTRIDGE" }, { "code": "C43184", "display": "CASE" }, { "code": "C43185", "display": "CELLO PACK" }, { "code": "C43186", "display": "CONTAINER" }, { "code": "C43187", "display": "CUP" }, { "code": "C43188", "display": "CUP, UNIT-DOSE" }, { "code": "C43189", "display": "CYLINDER" }, { "code": "C43190", "display": "DEWAR" }, { "code": "C43191", "display": "DIALPACK" }, { "code": "C96141", "display": "Dish, Petri" }, { "code": "C43192", "display": "DOSE PACK" }, { "code": "C43193", "display": "DRUM" }, { "code": "C96144", "display": "Flask" }, { "code": "C79135", "display": "FLEXIBLE INTERMEDIATE BULK CONTAINER" }, { "code": "C16738", "display": "INHALER" }, { "code": "C43194", "display": "INHALER, REFILL" }, { "code": "C43195", "display": "JAR" }, { "code": "C43196", "display": "JUG" }, { "code": "C43197", "display": "KIT" }, { "code": "C48626", "display": "NOT STATED" }, { "code": "C43233", "display": "PACKAGE" }, { "code": "C43198", "display": "PACKAGE, COMBINATION" }, { "code": "C43199", "display": "PACKET" }, { "code": "C79136", "display": "PAIL" }, { "code": "C82332", "display": "PATCH" }, { "code": "C96142", "display": "Plate, Microwell" }, { "code": "C43200", "display": "POUCH" }, { "code": "C43201", "display": "SUPERSACK" }, { "code": "C43202", "display": "SYRINGE" }, { "code": "C43203", "display": "SYRINGE, GLASS" }, { "code": "C43204", "display": "SYRINGE, PLASTIC" }, { "code": "C43205", "display": "TABMINDER" }, { "code": "C43206", "display": "TANK" }, { "code": "C53438", "display": "TRAY" }, { "code": "C42794", "display": "TUBE" }, { "code": "C43207", "display": "TUBE, WITH APPLICATOR" }, { "code": "C43226", "display": "VIAL" }, { "code": "C43208", "display": "VIAL, DISPENSING" }, { "code": "C43209", "display": "VIAL, GLASS" }, { "code": "C43210", "display": "VIAL, MULTI-DOSE" }, { "code": "C43211", "display": "VIAL, PATENT DELIVERY SYSTEM" }, { "code": "C43212", "display": "VIAL, PHARMACY BULK PACKAGE" }, { "code": "C43213", "display": "VIAL, PIGGYBACK" }, { "code": "C43214", "display": "VIAL, PLASTIC" }, { "code": "C43215", "display": "VIAL, SINGLE-DOSE" }, { "code": "C43216", "display": "VIAL, SINGLE-USE" }, { "code": "C49487", "display": "No" }, { "code": "C49488", "display": "Yes" }, { "code": "C82533", "display": "Active Ingredient" }, { "code": "C2140", "display": "Adjuvant" }, { "code": "C42637", "display": "Inactive Ingredient" }, { "code": "C1909", "display": "Product" }, { "code": "C45306", "display": "SUBSTANCE" }, { "code": "C176637", "display": "Absorption Modifying Excipient" }, { "code": "C89528", "display": "Adhesive Device" }, { "code": "C176642", "display": "Adsorbent" }, { "code": "C176643", "display": "Air Displacement Agent" }, { "code": "C275", "display": "Antioxidant" }, { "code": "C42647", "display": "Binder Excipient" }, { "code": "C70815", "display": "Buffer" }, { "code": "C176644", "display": "Bulking Excipient" }, { "code": "C176645", "display": "Carrier Excipient" }, { "code": "C360", "display": "Chelating Agent" }, { "code": "C42656", "display": "Color Excipient" }, { "code": "C176646", "display": "Complexing Excipient" }, { "code": "C53306", "display": "Cryoprotective Agent" }, { "code": "C176647", "display": "Denaturant" }, { "code": "C42648", "display": "Disintegrant Excipient" }, { "code": "C42662", "display": "Dispersing Excipient" }, { "code": "C927", "display": "Drug Vehicle" }, { "code": "C176638", "display": "Effervescent Excipient" }, { "code": "C176632", "display": "Emollient Excipient" }, { "code": "C73477", "display": "Emulsifying Excipient" }, { "code": "C176633", "display": "Emulsion Stabilizing Excipient" }, { "code": "C42650", "display": "Filler Excipient" }, { "code": "C176648", "display": "Film Coating Excipient" }, { "code": "C176634", "display": "Foam Stabilizing Excipient" }, { "code": "C176649", "display": "Free Radical Scavenging Excipient" }, { "code": "C176650", "display": "Gelling Excipient" }, { "code": "C42654", "display": "Glidant Excipient" }, { "code": "C176651", "display": "Humectant Excipient" }, { "code": "C42653", "display": "Lubricant Excipient" }, { "code": "C176652", "display": "Lyophilization Excipient" }, { "code": "C176653", "display": "Matrix Forming Excipient" }, { "code": "C176654", "display": "Microencapsulating Excipient" }, { "code": "C176655", "display": "Ointment Base" }, { "code": "C176656", "display": "Opacifying Excipient" }, { "code": "C176660", "display": "Ophthalmic Polymer" }, { "code": "C176635", "display": "Organoleptic Excipient" }, { "code": "C176657", "display": "Osmotic Excipient" }, { "code": "C55826", "display": "Plasticizer" }, { "code": "C176659", "display": "Polishing Excipient" }, { "code": "C42659", "display": "Preservative Excipient" }, { "code": "C42657", "display": "Printing Ink Excipient" }, { "code": "C176661", "display": "Propellant" }, { "code": "C176639", "display": "Reducing Excipient" }, { "code": "C176662", "display": "Release Modifying Excipient" }, { "code": "C176640", "display": "Solubilizing Excipient" }, { "code": "C45790", "display": "Solvent" }, { "code": "C176636", "display": "Stabilizing Excipient" }, { "code": "C176663", "display": "Suppository Base" }, { "code": "C42739", "display": "Surfactant Excipient" }, { "code": "C42660", "display": "Suspending Excipient" }, { "code": "C176641", "display": "Tonicity Excipient" }, { "code": "C176664", "display": "Transdermal Delivery Excipient" }, { "code": "C176665", "display": "Transfer Ligand Excipient" }, { "code": "C176666", "display": "Viscosity Modifying Excipient" }, { "code": "C176667", "display": "Water Repelling Excipient" }, { "code": "C176668", "display": "Wetting Excipient" }, { "code": "C176658", "display": "pH Modifying Excipient" }, { "code": "C176816", "display": "Degradation Product" }, { "code": "C185190", "display": "Elemental Impurities" }, { "code": "C176815", "display": "Residual Solvent" }, { "code": "C134001", "display": "Inorganic" }, { "code": "C176812", "display": "Process Related/Process" }, { "code": "C185192", "display": "Leachables" }, { "code": "C176813", "display": "Product Related" }, { "code": "C92081", "display": "Microbiological" }, { "code": "C48793", "display": "EQ" }, { "code": "C61585", "display": "LT (less than)" }, { "code": "C61584", "display": "MT (more than)" }, { "code": "C61583", "display": "NLT (not less than)" }, { "code": "C61586", "display": "NMT (not more than)" }, { "code": "C176793", "display": "BP" }, { "code": "C134009", "display": "Company Standard" }, { "code": "C134007", "display": "EP" }, { "code": "C134008", "display": "JP" }, { "code": "C134006", "display": "USP-NF" }, { "code": "C14182", "display": "Animal" }, { "code": "C18634", "display": "Animal Sources" }, { "code": "C48807", "display": "Chemical" }, { "code": "C14225", "display": "Human" }, { "code": "C14227", "display": "Insect" }, { "code": "C14329", "display": "Microbial" }, { "code": "C14258", "display": "Plant" }, { "code": "C25425", "display": "Approved" }, { "code": "C134011", "display": "Not Approved" }, { "code": "C134012", "display": "Reported in a CBE or AR" }, { "code": "C134010", "display": "Tentatively Approved" }, { "code": "C134021", "display": "Drug Product" }, { "code": "C134022", "display": "Drug Substance" }, { "code": "C133931", "display": "Raw Materials/Excipients/Intermediates/Reagents" }, { "code": "C134005", "display": "CFN" }, { "code": "C134003", "display": "DUNS" }, { "code": "C134004", "display": "FEI" }, { "code": "C17998", "display": "Unknown" }, { "code": "C133936", "display": "20 +/- 5 degrees C" }, { "code": "C134018", "display": "25 +/- 2 degrees C/40% +/- 5%RH" }, { "code": "C134014", "display": "25 +/- 2 degrees C/60% +/- 5%RH" }, { "code": "C134015", "display": "30 +/- 2 degrees C/65% +/- 5%RH" }, { "code": "C134017", "display": "30 +/- 2 degrees C/75% +/- 5%RH" }, { "code": "C134019", "display": "30 degrees C +/- 2 degrees C/35%RH +/- 5%RH" }, { "code": "C134016", "display": "40 +/- 2 degrees C/75% +/- 5%RH" }, { "code": "C133940", "display": "40 degrees C +/- 2 degrees C/not more than (NMT) 25%RH" }, { "code": "C133935", "display": "5 +/- 3 degrees C" }, { "code": "C96148", "display": "Proprietary" }, { "code": "C45420", "display": "Activity" }, { "code": "C168628", "display": "Mass" }, { "code": "C96164", "display": "CFR" }, { "code": "C96102", "display": "Compendial" }, { 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