Medicinal Product and Medicinal Product Forms

This Editorial Guide is used for Education Purposes Only. It is used in the Authoring Courses and Certifications. It is based on the January 2026 Editorial Guide.

When a clinical drug is created, the following supertypes must either already exist or must be created:

Medicinal Product containing onlychevron-rightMedicinal Product containingchevron-rightMedicinal Product Form (MPF)chevron-right

For example,

1172863005 Paracetamol 1 g oral tablet has the following supertypes:

These concepts in the International Release, their descriptions, and their |Has active ingredient (attribute)| value, represent the base ingredient, not a modification.

For example,

1204319004 |Product containing precisely retinol (as retinol palmitate) 50000 unit/1 milliliter conventional release solution for injection (clinical drug)| has medicinal product and medicinal product form supertypes with retinol , not retinol palmitate. Retinol palmitate is a modification of Retinol and thus should not be used in the creation of the medicinal product and medicinal product form supertypes.

Exceptions to use a modified substance are explicitly identified below:

Exceptions
Elucidation
Examples

Benzylpenicillin

When the active ingredient has an Is modification of (attribute) value of 323389000 |Benzylpenicillin (substance)|.

1234765004 |Product containing only benzathine benzylpenicillin in parenteral dose form (medicinal product form)|

323404007 |Product containing benzathine benzylpenicillin (medicinal product)|

Benzylpenicillin is the base, but use the modified substance in the FSN for the MP/MPF.

Chemical element compound with multiple modification

Instances where the chemical element compound has two or more Is Modification of (attribute)s

422232005 |Calcium lactate gluconate (substance)|

-Has |Is modification of (attribute)| = Calcium gluconate

-Has |Is modification of (attribute)| = Calcium lactate

1359973006 |Copper (64-Cu) labeled somatostatin analog (substance)|

-Has |Is modification of (attribute)| = Somatostatin analog

-Has |Is modification of (attribute)| = Copper-64

Chloral hydrate

273948005 |Chloral hydrate (substance)| is a modification of Chloral. However, chloral is unstable on its own and always exists in the hydrated form.

778711000 |Product containing only chloral hydrate in oral dose form (medicinal product form)|

386735001 |Product containing chloral hydrate in oral dose form (medicinal product form)|

775158004 |Product containing only chloral hydrate (medicinal product)|

Liposome or lipid complex substances

< 414612001 |Liposomal agent (substance) These subtypes have some sort of modification, but they can be used to create:

  • Product containing only x (medicinal product)

  • Product containing only x in y dose form (medicinal product form)

Do not use to create:

  • Product containing x (medicinal product)

  • Product containing x in y dose form (medicinal product form)

426490000 |Vincristine liposome (substance)|

425953004 |Amphotericin B lipid complex (substance)|

768664009 |Amphotericin B phospholipid complex (substance)|

427544000 |Amphotericin B cholesteryl sulfate complex (substance)|

Pegylated substance

There is no technical way to identify these concepts, though they will often begin with peg-.

385544005 |Pegfilgrastim (substance)|

770965008 |Pegvaliase (substance)|

Radiopharmaceutical

< 89457008 Radioactive isotope (substance)|

783865003 |Product containing only cyanocobalamin (58-Co) (medicinal product)|

783867006 |Product containing only cyanocobalamin (58-Co) in oral dose form (medicinal product form)|

783856005 |Product containing sodium iodide (131-I) in parenteral dose form (medicinal product form)|

783854008 |Product containing sodium iodide (131-I) (medicinal product)|

Silver sulfadiazine

387112002 |Silver sulfadiazine (substance)| is a modification of 74523009 |Sulfadiazine (substance)|

864009007 |Product containing only silver sulfadiazine in cutaneous dose form (medicinal product form)|

771756000 |Product containing silver sulfadiazine in cutaneous dose form (medicinal product form)|

Sodium valproate

387481005 |Sodium valproate (substance)| is a modification of 387080000 |Valproic acid (substance)|

766519009 |Product containing precisely sodium valproate 40 milligram/1 milliliter conventional release oral solution (clinical drug)|

1204386001 |Product containing precisely sodium valproate 133 milligram and valproic acid 58 milligram/1 each prolonged-release oral tablet (clinical drug)|

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