Lutathera is a brand name of Lutetium lu 177 dotatate, a prescription medicine. The FDA NDC Directory lists 1 Lutathera product in 1 strength and form.

Aaa USA Inc holds the FDA application for Lutathera (NDA208700, approved January 26, 2018).

Is there a generic or store brand of Lutathera?

Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Lutathera product. Ask your pharmacist whether one is right for you.

Lutathera (Lutetium lu 177 dotatate): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Lutathera?: Lutathera is a brand name of Lutetium lu 177 dotatate, a prescription medicine. The FDA NDC Directory lists 1 Lutathera product in 1 strength and form.
Who makes Lutathera?: Aaa USA Inc holds the FDA application for Lutathera (NDA208700, approved January 26, 2018).
Is there a generic or store brand of Lutathera?: Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Lutathera product. Ask your pharmacist whether one is right for you.
Has Lutathera been recalled?: No recall linked to Lutathera products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Lutathera is

Each Lutathera product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Lutetium lu 177 dotatate · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
lutetium oxodotreotide LU-177 10 mCi/mL injection (intravenous)	Lutathera	1 product, 1 company	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lutetium lu 177 dotatate →

FDA approval

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

FDA applications of Lutathera products (Drugs@FDA)
Application	Holder	First approved	Products
NDA208700	Aaa USA Inc	January 26, 2018	1

Companies that list Lutathera

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Lutathera products.

Advanced Accelerator Applications USA, Inc1 product

Recalls

No recall linked to Lutathera products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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Lutathera