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

Janssen Biotech holds the FDA application for Inlexzo (NDA219683, approved September 9, 2025).

Is there a generic or store brand of Inlexzo?

Other products of Gemcitabine are listed with the FDA, but none in exactly the same strength and form as a Inlexzo product.

Inlexzo (Gemcitabine): 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 Inlexzo?: Inlexzo is a brand name of Gemcitabine, a prescription medicine. The FDA NDC Directory lists 1 Inlexzo product in 1 strength and form.
Who makes Inlexzo?: Janssen Biotech holds the FDA application for Inlexzo (NDA219683, approved September 9, 2025).
Is there a generic or store brand of Inlexzo?: Other products of Gemcitabine are listed with the FDA, but none in exactly the same strength and form as a Inlexzo product.
Has Inlexzo been recalled?: No recall linked to Inlexzo products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Inlexzo is

Each Inlexzo 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.

Gemcitabine · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
gemcitabine 225 mg system (intravesical)	Inlexzo	None listed	—

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

FDA approval

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

FDA applications of Inlexzo products (Drugs@FDA)
Application	Holder	First approved	Products
NDA219683	Janssen Biotech	September 9, 2025	1

Companies that list Inlexzo

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

Janssen Biotech, Inc.1 product

Recalls

No recall linked to Inlexzo 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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Inlexzo