Every FDA label behind this catalogue

A prescription label is the prescribing information: the document a manufacturer files and the FDA approves, setting out what the medication is approved to treat, at what doses, with which warnings. Products sold over the counter carry a shorter Drug Facts label instead, and the two are not built the same way, which is why pages here say which kind they are quoting.

Every prescription label opens with Highlights, a summary the regulator requires, followed by the full text. The two overlap heavily, and the same fact often appears twice in different words. Pages on this site remove that repetition and keep the fuller wording.

An application number beginning with NDA is a new drug application: the original approval, with its own clinical evidence. One beginning with ANDA is an abbreviated application, which is how generics are approved against an existing product. The number is the stable identifier of the approval, while brand names come and go.

The version and date are of the specific document these pages were built from. Labels are revised, and a page built from a superseded version can be wrong, so the date is shown rather than hidden. The newest here is the Ozempic injection label of 30 July 2026; the oldest is Differin gel, 7 December 2022.

A boxed warning is the strongest warning the FDA can require. Where several labels carry the same one, it belongs to the class of medication rather than to the product.