What do these terms mean?

The medicine itself

Drug also called active ingredient

The chemical that does the work in your body.Example: tirzepatide

Generic name

The official scientific name of that ingredient. Every company uses the same one.Example: tirzepatide

Brand name

The trademarked name a company sells the drug under. One ingredient can have several brands, each approved for different uses.Example: Mounjaro (for diabetes) and Zepbound (for weight loss) are both tirzepatide, made by Eli Lilly.

Generic drug

A lower-cost copy made by another company after the patent expires. Same ingredient, works the same way.Example: Lipitor is the brand; “atorvastatin calcium” tablets from other makers are generics.

Watch out: “generic” is used two ways. A generic name is what the ingredient is called. A generic drug is a lower-cost copy.

The label

Label also called prescribing information or package insert

The official, FDA-approved document for a medicine. It is the long folded paper in the box with tiny print, covering what the drug is for, how to take it, side effects and warnings.

Indication

The official reason to use the drug: the condition the FDA approved it for. It is section 1 of the label.Example: Mounjaro has two: type 2 diabetes, and lowering heart risk in people with type 2 diabetes.

Label version

Labels are updated when new uses or warnings are approved. Each update gets a new version number and effective date.Example: Mounjaro’s heart-risk indication was added in a recent label update.

Approval

FDA application

The company’s formal request to sell the drug. Each has a number:

NDA New Drug Application, for a new medicine
ANDA Abbreviated NDA, for a generic copy
BLA Biologics License Application, for medicines made from living cells (such as Humira)

Example: Mounjaro is NDA215866.

Approved

The FDA reviewed the evidence and allowed the drug to be sold for its indications.

Manufacturer and repackager

The manufacturer makes the drug (Eli Lilly). A repackager buys it and repackages it, for example into smaller packs for clinics, and files its own copy of the label. Those copies can be out of date, so the app uses only the newest label for each application.

Prescription and over-the-counter (OTC)

A prescription drug needs a doctor’s order. An OTC drug is sold off the shelf, like Advil.

Medical terms on the site

ICD-10 code ICD-10-CM in the U.S.

A standard code for a diagnosis, used on medical records and insurance claims worldwide. The FDA does not assign these; this site adds them.Examples: E11 type 2 diabetes · I10 high blood pressure · E78.5 high cholesterol

MACE

“Major adverse cardiovascular events”: doctor shorthand for heart attack, stroke, or death from heart disease. A drug that “reduces MACE” lowers the chance of those.

Rx

The standard symbol for a prescription.

Where the data comes from

FDA

The U.S. Food and Drug Administration, the government agency that approves medicines.

openFDA

The FDA’s free public database that this app reads from on every search. open.fda.gov ↗

Drugs@FDA

The FDA’s record of every drug approval: who, what and when.

DailyMed

The National Library of Medicine’s website with the official copy of every drug label. The “Source” links in the app go there. dailymed.nlm.nih.gov ↗