Manufactured drug form en
A manufactured drug form is a specific version of a drug formulation that is manufactured, packaged, labeled, marketed, and made available by a specific organization within a given market, region, or jurisdiction. Typically such manufactured forms are separately labeled and are subject to regulation or other safety and efficacy standards. Note: manufactured drug forms are typically named by the combination of their trade name, dosage strength, and dosage form, for example "Advil 200mg tablet" [ - ]
What are Properties? Properties
| Property | ID | Expected Type | Description | |
|---|---|---|---|---|
| Manufacturer | /medicine/manufactured_drug_form/manufacturer | /medicine/drug_manufacturer |
The manufacturer of this version of a drug formulation. As there may be many organizations that cooperate to bring a drug to market, this property should be set to the organization that ultimately markets the drug to users, typically also the one that is listed on the drug's label. , , |
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| Manufactured form of | /medicine/manufactured_drug_form/manufactured_form_of | /medicine/drug_formulation |
The drug formulation available in this manufactured form |
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| Available in | /medicine/manufactured_drug_form/available_in | /location/country |
The country or countries in which this specific labeled drug form is available. |
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| Generic drug | /medicine/manufactured_drug_form/generic_drug | /type/boolean |
'Yes' if this topic is known to be a generic form of a drug. 'No' if this topic is known to be a non-generic (proprietary) form of a drug. |
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| Label date | /medicine/manufactured_drug_form/label_date | /type/datetime |
Revision date of the label information for this drug |
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| Label link | /medicine/manufactured_drug_form/label_link | /type/uri |
Link to this dosage form's drug label on the corresponding regulatory authority's web site, e.g. US NLM DailyMed site. |
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| Label sections | /medicine/manufactured_drug_form/label_sections | /medicine/drug_label_section |
Sections of information contained in the drug label, such as Indications, Contraindications, Box warning, etc. |
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| Discontinued | /medicine/manufactured_drug_form/discontinued | /type/boolean |
Yes if this drug form is discontinued, No if actively marketed/sold. |
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| Marketing start date | /medicine/manufactured_drug_form/marketing_start_date | /type/datetime |
Date on which this drug form was first marketed / made available. |
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| Marketing end date | /medicine/manufactured_drug_form/marketing_end_date | /type/datetime |
Date on which this drug form was discontinued (if applicable). |
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| Patents | /medicine/manufactured_drug_form/patents | /law/us_patent |
Any patents that protect this drug/drug form. |
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| Patent expiry date | /medicine/manufactured_drug_form/patent_expiry_date | /type/datetime |
Date on which the last patent(s) protecting this drug/drug form expire |
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| NDC Product ID | /medicine/manufactured_drug_form/ndc_product_id | /type/rawstring |
The NDC product code(s) for this manufactured drug product (US) |
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| FDA application number | /medicine/manufactured_drug_form/fda_application_num | /type/rawstring |
The FDA application number, for US drugs and biologics regulated by the FDA under NDA, ANDA, or BLA application processes. Drugs may have multiple application numbers if they have been reformulated at some point in their history. |
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| FDA OTC monograph part | /medicine/manufactured_drug_form/fda_otc_part | /medicine/fda_otc_monograph_part |
For US OTC drugs, the FDA OTC monograph part under which the drug is regulated. |
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| Color | /medicine/manufactured_drug_form/color | /visual_art/color |
For solid oral dosage forms (tablets, etc), color of product. |
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| Flavor | /medicine/manufactured_drug_form/flavor | /medicine/drug_dosage_flavor |
The flavor of this drug's dosage form, if applicable. For example, cherry, strawberry, etc. |
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| Shape | /medicine/manufactured_drug_form/shape | /medicine/drug_form_shape |
For solid oral dosage forms (tablets, etc), shape of product. , |
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| Size | /medicine/manufactured_drug_form/size | /type/float mm |
For solid oral dosage forms (tablets, etc), size of product, in mm. |
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| Scoring | /medicine/manufactured_drug_form/scoring | /type/int |
For solid oral dosage forms (tablets, etc), scoring of product. The value is the number of equal-sized pieces the product can be broken into using score marks. So a "1" represents a non-scored product, "2" can be broken into two equal pieces, "3" can be broken into 3 equal pieces, etc. |
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| Imprint | /medicine/manufactured_drug_form/imprint | /type/rawstring |
The imprint on the manufactured dosage form. |
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| Coating | /medicine/manufactured_drug_form/coating | /type/boolean |
For solid oral dosage forms, 'Yes' if it has one or more coatings, such as sugar coating, film coating, or enteric coating. Only coatings to the external surface or the dosage form should be considered (for example, coatings to individual pellets or granules inside a capsule or tablet are excluded from consideration). |
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| Symbol mark | /medicine/manufactured_drug_form/symbol_mark | /type/boolean |
For solid oral dosage forms, 'No' if the medicinal product has a mark or symbol appearing on it for easy and definite recognition. Score lines, letters, numbers, and internal and external cut-outs are not considered marks or symbols. |
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| Therapeutic equivalents | /medicine/manufactured_drug_form/therapeutic_equivalents | /medicine/drug_therapeutic_equivalence_relationship |
Other manufactured drug forms that are therapeutically equivalent, or bioequivalent, to this form. Therapeutic equivalence is defined as being pharmaceutically equivalent and being demonstrated through in vitro or in vivo studies to have the same clinical effect and safety profile. |
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What are Included Types? Included Types
| delete /common/topic | |||
|---|---|---|---|
| delete /business/consumer_product | |||
This type doesn't have any included types. |
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Incoming Properties
| Originating Type | Property | ||
|---|---|---|---|
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Drug formulation
/medicine/drug_formulation
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Reference form
/medicine/drug_formulation/reference_form
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Drug formulation
/medicine/drug_formulation
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Manufactured forms
/medicine/drug_formulation/manufactured_forms
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Drug label section
/medicine/drug_label_section
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Subject manufactured drug
/medicine/drug_label_section/subject_drug
|
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Drug form shape
/medicine/drug_form_shape
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Drugs with this shape
/medicine/drug_form_shape/drugs_with_this_shape
|
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Drug manufacturer
/medicine/drug_manufacturer
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Drugs manufactured
/medicine/drug_manufacturer/drugs_manufactured
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FDA OTC drug monograph part
/medicine/fda_otc_monograph_part
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Drugs regulated
/medicine/fda_otc_monograph_part/drugs_regulated
|
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Drug therapeutic equivalence relationship
/medicine/drug_therapeutic_equivalence_relationship
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Equivalent
/medicine/drug_therapeutic_equivalence_relationship/equivalent
|
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Drug dosage flavor
/medicine/drug_dosage_flavor
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Drugs with this flavor
/medicine/drug_dosage_flavor/drugs_with_this_flavor
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