Ozempic is Novo Nordisk's brand of semaglutide for type 2 diabetes. It is the most searched name in the GLP-1 class, and much of what people believe about it describes a different label: the weight-management approvals belong to Wegovy, which contains exactly the same molecule. Ozempic itself is a diabetes medicine whose label has grown twice since 2017, first to cover heart risk and then kidney risk, and whose name now also sits on a tablet.
Every statement below comes from one of four FDA-side records — the June 2026 Ozempic label on DailyMed, the application history and approval letters in Drugs@FDA, the Orange Book's product list, and the drug shortage database — checked on 5 October 2026.
Three approved uses, all in type 2 diabetes
| Approved use (adults with type 2 diabetes) | Added | FDA record |
|---|---|---|
| Blood-sugar (glycaemic) control, alongside diet and exercise | 5 December 2017 | original approval, NDA 209637 |
| Fewer heart attacks, strokes and cardiovascular deaths (the three-part "MACE" outcome) in those with established cardiovascular disease | 16 January 2020 | supplement 3 |
| To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in those with chronic kidney disease | 28 January 2025 | supplement 25 |
Wording condensed from the label's section 1; each date is the approval date Drugs@FDA records for that supplement. The kidney letter describes supplement 25 as providing "for a new indication".
Each row is narrower than it sounds. The cardiovascular indication covers people who already have heart or vascular disease, not everyone with diabetes. The kidney indication covers people whose diabetes has already damaged their kidneys. The trials behind both rows — SUSTAIN 6 and FLOW — and how their populations differ from the label wording are on Mounjaro vs Ozempic; the blood-sugar trial record is on Ozempic for type 2 diabetes.
What the label does not cover is just as useful. Ozempic is not approved for weight management, for type 1 diabetes or for children. Its trials recorded weight loss, and many prescriptions are written with weight in mind, but the label's indications do not include it. That gap is the whole reason two semaglutide brands exist.
The molecule and its mechanism
Semaglutide is close to the body's own GLP-1 — 94% of the sequence is shared, by the label's count — and acts on the same receptor. What makes it last a week instead of minutes is chemistry at three positions in the chain: position 8 is altered so the DPP-4 enzyme cannot cut it, position 26 carries an 18-carbon fatty acid that makes the drug ride on albumin in the bloodstream (the label's chief explanation for its long life), and position 34 is adjusted so only one fatty acid attaches. Yeast fermentation makes the peptide backbone. Molecular weight: 4,113.58 g/mol.
How it lowers blood sugar is stated precisely: it "stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner", so the effect switches on when glucose is high, and "a minor delay in gastric emptying in the early postprandial phase" contributes. The label is candid about the limit of that explanation: "the mechanism of kidney-related risk reduction has not been established."
That glucose-dependence is the core difference from insulin, set out on our page comparing GLP-1 drugs with insulin. The broader biology is on how GLP-1 works, and the molecule itself has an entry on Peptide Lexicon's semaglutide page.
Every form FDA lists
| Form | What it holds | Listed by FDA | Status |
|---|---|---|---|
| Pen, 2 mg/1.5 mL | multiple weekly doses | 5 December 2017 | discontinued |
| Pen, 4 mg/3 mL | 4 weekly doses | 9 April 2019 | marketed |
| Pen, 8 mg/3 mL | 4 weekly doses at the 2 mg strength | 28 March 2022 | marketed |
| Pen, 2 mg/3 mL | the starting-strength pen | 6 October 2022 | marketed |
| Single-dose prefilled syringes, 0.25, 0.5 and 1 mg | 1 dose each | 5 May 2026 | marketed |
| Tablets, 1.5, 4 and 9 mg (NDA 213051) | once daily | strengths approved 9 December 2024; now sold under the Ozempic name | marketed |
Orange Book product file dated 11 September 2026; device descriptions from section 3 of the June 2026 injection label and the joint Rybelsus/Ozempic tablet label.
Two changes in that table are recent and easy to miss. The syringes are the first Ozempic presentation that is not a multi-dose pen: one syringe, one weekly dose. And the tablets are not a new medicine but a renaming of oral semaglutide. They share a label and an application with Rybelsus, whose three strengths FDA's shortage database lists as "To Be Discontinued" (dated 4 June 2026, unchanged on 5 October 2026); the label states the two tablets "are not substitutable on a mg-to-mg basis". The full tablet story is on the Ozempic pill. Pen storage limits for every brand are on GLP-1 pen storage, and strengths and schedules sit with Peptifact's semaglutide dosage page.
The same molecule as Wegovy: why the brand split matters
Novo Nordisk filed Wegovy as its own application, approved in June 2021, with higher top strengths and a weight indication; heart and liver uses followed. Payers and Medicare's statutory bar on weight-loss drugs look at the indication on the label rather than at the molecule inside — so one prescription for semaglutide may be reimbursed as Ozempic in diabetes while another for the same molecule is refused as Wegovy. How that works is on GLP-1 insurance coverage, and the two brands side by side on Wegovy vs Ozempic. The other semaglutide brand's own record is on what is Wegovy?. The label adds that Ozempic should not be combined with other semaglutide products or other GLP-1 drugs.
Tirzepatide's equivalent pair — Mounjaro for diabetes, Zepbound for weight — is set out on Zepbound vs Ozempic and Mounjaro vs Zepbound.
Safety record on the label
| Label section | What it says for Ozempic |
|---|---|
| Boxed warning | Rodent thyroid C-cell tumours; human relevance "has not been determined" |
| Not to be used | Personal or family history of medullary thyroid cancer or MEN 2; prior serious allergy to semaglutide or an excipient |
| Warnings | Pancreatitis · worsening diabetic eye disease · hypoglycaemia alongside insulin or sulfonylureas · dehydration-related kidney injury · severe stomach and bowel reactions · allergy · gallbladder disease · aspiration during anaesthesia |
| Most common (≥5%) | Nausea, vomiting, diarrhoea, abdominal pain, constipation |
The trial figures behind each line are on Ozempic side effects. Which of them matters for an individual is a question for a prescriber, not for this page.
Prescription, price and patents
A prescription is required. Prices — list and self-pay — are tracked on what Ozempic costs; Novo Nordisk's direct-fill service is on NovoCare Pharmacy; and the earliest date a generic semaglutide could reach US shelves, from the patent and exclusivity listings, is on when will Ozempic go generic?.
Sources
Ozempic (semaglutide) injection prescribing information, revised 06/2026, DailyMed set adec4fd2-6858-4c99-91d4-531f5f2a2d79 · Rybelsus and Ozempic tablets prescribing information, DailyMed set 27f15fac-7d98-4114-a2ec-92494a91da98 · Drugs@FDA application records for NDA 209637 and NDA 213051 via openFDA · FDA approval letters for NDA 209637 supplements 3 (2020-01-16), 9 (2022-03-28) and 25 (2025-01-28) · FDA Orange Book product file dated 11 September 2026 · FDA drug shortage database (Rybelsus entries) via openFDA. All read 5 October 2026.