Omlyclo is a brand name of Omalizumab, a prescription medicine. The FDA NDC Directory lists 3 Omlyclo products in 3 strengths and forms.

Celltrion Inc holds the FDA application for Omlyclo (BLA761399, approved March 7, 2025).

Is there a generic or store brand of Omlyclo?

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

Omlyclo (Omalizumab): 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 Omlyclo?: Omlyclo is a brand name of Omalizumab, a prescription medicine. The FDA NDC Directory lists 3 Omlyclo products in 3 strengths and forms.
Who makes Omlyclo?: Celltrion Inc holds the FDA application for Omlyclo (BLA761399, approved March 7, 2025).
Is there a generic or store brand of Omlyclo?: Other products of Omalizumab are listed with the FDA, but none in exactly the same strength and form as a Omlyclo product.
Has Omlyclo been recalled?: No recall linked to Omlyclo products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Omlyclo is

Each Omlyclo 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.

Omalizumab · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
omalizumab 150 mg/mL injection (subcutaneous)	Omlyclo	None listed	—
omalizumab 300 mg/2 mL injection (subcutaneous)	Omlyclo	None listed	—
omalizumab 75 mg/0.5 mL injection (subcutaneous)	Omlyclo	None listed	—

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

FDA approval

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

FDA applications of Omlyclo products (Drugs@FDA)
Application	Holder	First approved	Products
BLA761399	Celltrion Inc	March 7, 2025	3

Companies that list Omlyclo

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

CELLTRION USA, Inc.3 products

Recalls

No recall linked to Omlyclo 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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Omlyclo