Darzalex is a brand name of Daratumumab, a prescription medicine. The FDA NDC Directory lists 1 Darzalex product in 1 strength and form.

Janssen Biotech holds the FDA application for Darzalex (BLA761036, approved November 16, 2015).

Is there a generic or store brand of Darzalex?

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

Darzalex (Daratumumab): 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 Darzalex?: Darzalex is a brand name of Daratumumab, a prescription medicine. The FDA NDC Directory lists 1 Darzalex product in 1 strength and form.
Who makes Darzalex?: Janssen Biotech holds the FDA application for Darzalex (BLA761036, approved November 16, 2015).
Is there a generic or store brand of Darzalex?: Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Darzalex product. Ask your pharmacist whether one is right for you.
Has Darzalex been recalled?: No recall linked to Darzalex products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Darzalex is

Each Darzalex 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.

Daratumumab · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
daratumumab 100 mg/5 mL injection, solution, concentrate (intravenous)	Darzalex	1 product, 1 company	—

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

FDA approval

BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

FDA applications of Darzalex products (Drugs@FDA)
Application	Holder	First approved	Products
BLA761036	Janssen Biotech	November 16, 2015	1

Companies that list Darzalex

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

Janssen Biotech, Inc.1 product

Recalls

No recall linked to Darzalex 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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Darzalex