Drug data glossary, defined once.

The licence a regulator grants to put a medicine on its market — national, or EU-wide through the European Medicines Agency’s centralised procedure.

Authorised is not the same as available: a holder can keep an authorisation without ever marketing the product, and one substance can be authorised under different brands, holders and pack sizes in each country. The company that holds it is the marketing authorisation holder (MAH).

Defined by European Medicines Agency and national competent authoritiesSee where a medicine is registered

The regulator-approved description of a medicine for prescribers: indications, dosing, contraindications, interactions and side effects.

It is part of the marketing authorisation, so its wording is the one the regulator accepted, not the manufacturer’s marketing copy. The US counterpart is the prescribing information (the “label”); in Switzerland it is the Fachinformation.

Defined by European Commission (Directive 2001/83/EC) and the EMARead label text

The plain-language leaflet inside every pack, written for the patient from the same approved information as the SmPC.

Where the leaflet and the SmPC seem to disagree, it is usually because the leaflet simplifies; the SmPC is the fuller statement.

Defined by European Commission (Directive 2001/83/EC) and the EMA

The Global Trade Item Number behind a pack’s barcode — it identifies one pack size of one product, not the medicine in general.

GTINs are 8, 12, 13 or 14 digits; European medicine packs usually carry a 13-digit one as an EAN-13 barcode. Under the EU Falsified Medicines rules, prescription packs also carry a 2D DataMatrix code holding a product code — commonly the GTIN — with a serial number, batch and expiry. In Switzerland a medicine’s GTIN starts 7680, followed by its Swissmedic authorisation number and pack code.

Defined by GS1Look a pack code up

The five-digit number Swissmedic assigns when it authorises a medicine; a three-digit pack code then distinguishes each pack under it.

One authorisation number can cover several strengths and pack sizes, so it identifies the product, not the pack. The pack-level key is the GTIN, which embeds both numbers.

Defined by SwissmedicLook a pack code up

A seven-digit Swiss article number for pharmacy products, long used by Swiss pharmacy and wholesale software to key a pack.

It is assigned by HCI Solutions, not by a regulator — Swissmedic does not issue it — so it says nothing about authorisation. The GTIN is the open standard for the same job.

Defined by HCI SolutionsLook a pack code up

Germany’s eight-digit pharmacy article number — the pack identifier German pharmacy software and claims run on.

It identifies one pack, like a GTIN. Numbers issued before 2013 had seven digits and were converted by adding a leading zero.

Defined by IFA (Informationsstelle für Arzneispezialitäten)Look a pack code up

France’s two codes: the eight-digit CIS identifies a medicine in the national database (BDPM); the 13-digit CIP identifies each of its packs.

Join on CIS to group a product’s packs; join on CIP13 to match a pack scanned at a counter.

Defined by ANSM (Agence nationale de sécurité du médicament)Look a pack code up

The US 10-digit drug code in three segments — labeler, product, package — so one NDC identifies one pack of one product.

The ten digits come in three layouts (4-4-2, 5-3-2, 5-4-1). Billing systems and CMS files such as NADAC pad them to 11 digits (5-4-2), so the same pack can appear with and without a leading zero. An NDC in the FDA’s directory shows a product is listed, which is not the same as approved.

Defined by US Food and Drug AdministrationLook a pack code up

What the manufacturer charges — before the pharmacy and wholesaler margins that the patient ultimately pays.

Two products with the same ex-factory price can reach the counter at different prices, because the margin is set by a national scale, usually as a percentage that falls as the price rises.

Defined by Swiss BAG Specialty ListPrices by country

The price at the counter for one pack, margins and VAT included.

This is the figure a patient or an insurer sees. It is set per pack, so it is not comparable between countries until it is divided by a dose — see defined daily dose.

Defined by Swiss BAG Specialty ListPrices by country

The percentage of the price the patient pays themselves after the insurer's share — 10% for most reimbursed Swiss medicines, 20% for some.

A 20% rate is usually applied to an original product where a cheaper generic exists, as a nudge toward the generic. It is charged on top of the annual deductible, not instead of it.

Defined by Swiss KVG

The list of medicines Swiss basic insurance reimburses. A product not on it can still be sold — the patient just pays the whole price.

Inclusion carries a maximum price and often a limitation: a condition, a prescriber specialty, or a prior-authorisation requirement that must be met before the insurer pays.

Defined by Swiss Federal Office of Public Health

A condition attached to reimbursement: who may prescribe it, for which indication, or after which prior authorisation.

The drug is on the list either way. The limitation decides whether this particular prescription is paid for.

Defined by Swiss BAG Specialty List

What US retail pharmacies actually pay to acquire a drug, surveyed monthly by Medicaid — an acquisition cost, not a retail price.

It is published per unit (per tablet, per mL), not per pack, and it is what the pharmacy paid, so it sits below the price any patient or plan is charged.

Defined by US Centers for Medicare & Medicaid ServicesPrices by country

The WHO's assumed average daily dose for an adult on the drug's main indication — the unit that makes prices comparable across countries and pack sizes.

A DDD is a statistical unit of measurement, not a recommended dose, and for some drugs it is far from what anyone is actually prescribed. It exists so that a 30-tablet pack in Italy and a 100-tablet pack in Norway can be compared at all.

Defined by WHO Collaborating Centre for Drug Statistics MethodologyCompare prices per daily dose

A follow-on version of a biologic, approved on evidence that it behaves the same way — the closest a 148 kDa protein gets to a generic.

Unlike a small-molecule generic, a biosimilar is not chemically identical to its reference product; it is shown to be clinically equivalent. It is a different product, by a different manufacturer, at its own price.

A five-level WHO code filing a drug by organ system and then by chemical substance — C10AA05 is atorvastatin.

Only the fifth level names a substance. A shorter code names a category: A16AX is "Various alimentary tract and metabolism products", which is not an ingredient and must never be shown as one. One substance can also hold several codes, one per indication.

Defined by WHO Collaborating Centre for Drug Statistics MethodologyBrowse the ATC classification

How tightly the sale is controlled, A to E — A and B need a prescription, D and E do not.

This is the Swiss scale. C was abolished in 2019. The equivalent elsewhere has its own letters or words, so the category is only comparable within one country.

Defined by Swissmedic

The FDA's one-line answer to "what kind of drug is this" — the class named on the US label.

Defined by US Food and Drug Administration

The US controlled-substance tier, I to V, by abuse potential — I is the most restricted and has no accepted medical use.

Defined by US Drug Enforcement Administration

The international non-proprietary name — the one name for a substance that is the same in every country, unlike the brand.

The stem carries meaning: everything ending -mab is a monoclonal antibody, -statin an HMG-CoA reductase inhibitor, -prazole a proton-pump inhibitor.

Defined by World Health Organization

A molecule written as one line of text, so it can be pasted into a chemistry tool.

The same molecule has many valid SMILES strings, so two that differ are not necessarily two different molecules. Use the InChIKey to compare.

A fixed-length fingerprint of a structure — the same molecule always produces the same key, which makes it the right thing to match on.

The first block encodes the skeleton and the second the stereochemistry and charge, so two keys sharing a first block are usually the same skeleton in a different stereo or charge form. A salt is a different key altogether: the counter-ion is an extra component and changes the first block.

The FDA's unique identifier for a substance, including ones with no drawable structure — an antibody has a UNII but no SMILES.

Defined by US Food and Drug Administration

A concept id in the US National Library of Medicine's drug vocabulary, used to join a clinical system's records to ours.

Defined by US National Library of Medicine

The identifier of a compound in ChEMBL, the EBI's open bioactivity database — the key behind the structure picture and the binding data on this site.

Defined by EMBL-EBI

A structure someone actually measured, by X-ray, NMR or cryo-EM, deposited in the Protein Data Bank.

An experimental structure is a snapshot of one crystal or one particle, often of a fragment of the protein rather than all of it — the chain range says how much.

Defined by Worldwide Protein Data Bank

A predicted structure, not a measured one — useful, and not evidence.

Predictions are reliable for well-ordered domains and unreliable for flexible loops and disordered regions. Read the pLDDT before trusting any part of one.

Defined by DeepMind and EMBL-EBI

AlphaFold's confidence in its own prediction, 0 to 100, per residue — above 90 is reliable, below 50 usually means the region has no fixed shape.

A mean pLDDT across a whole protein hides the variation that matters: a model can average 85 and still be guessing at the loop you care about.

Defined by DeepMind and EMBL-EBI

How much detail an experimental structure resolves, in ångström — smaller is sharper, and below about 2.0 Å individual atoms are placed with confidence.

Defined by Worldwide Protein Data Bank

The most serious warning the FDA can require on a label, for a risk that can be fatal or disabling — printed inside a black border, which is where the name comes from.

It does not mean the drug should not be used. It means the risk must be weighed explicitly every time it is prescribed.

Defined by US Food and Drug AdministrationRead label text

The furthest a compound has got in clinical development — 4 means an approved medicine, 1 to 3 mean trials only.

Defined by ChEMBL

A compound that is inactive as swallowed and becomes the active drug once the body metabolises it.

It matters clinically because the conversion can depend on an enzyme a patient may lack — which is often exactly what the pharmacogenomic guidance on this page is about.

The meaningful ending of a generic name: -mab is a monoclonal antibody, -tinib a kinase inhibitor, -prazole a proton-pump inhibitor.

Defined by US Adopted Names Council

How tightly a drug holds its target. Lower concentrations mean a tighter grip — a drug working at 1 nM needs a thousand times less of itself than one working at 1 µM.

The p-prefixed forms are negative logarithms, so they run the other way: a higher pIC50 is a tighter binder. Values are measured in an assay, and assays differ — treat them as a ranking, not a constant.

Defined by IUPHAR/BPS Guide to Pharmacology

A peer-reviewed recommendation for changing a dose based on a patient's genotype — published only where the evidence supports acting on it.

Most medicines have no CPIC guideline. That is the normal case and not a gap in the data.

Defined by Clinical Pharmacogenetics Implementation Consortium

A report filed with the FDA that someone came to harm while taking a drug — a signal, not a finding of cause.

Counts track how widely a drug is used at least as much as how risky it is, and the same event may be reported several times. A high count on a common medicine is expected.

Defined by US Food and Drug Administration