What is BYNFEZIA Pen?

BYNFEZIA Pen is a brand name of Octreotide acetate, a prescription medicine. The FDA NDC Directory lists 1 BYNFEZIA Pen product in 1 strength and form.

Who makes BYNFEZIA Pen?

Sun Pharm holds the FDA application for BYNFEZIA Pen (NDA213224, approved September 27, 2024).

Is there a generic or store brand of BYNFEZIA Pen?

Other products of Octreotide acetate are listed with the FDA, but none in exactly the same strength and form as a BYNFEZIA Pen product.

BYNFEZIA Pen (Octreotide acetate): 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 BYNFEZIA Pen?: BYNFEZIA Pen is a brand name of Octreotide acetate, a prescription medicine. The FDA NDC Directory lists 1 BYNFEZIA Pen product in 1 strength and form.
Who makes BYNFEZIA Pen?: Sun Pharm holds the FDA application for BYNFEZIA Pen (NDA213224, approved September 27, 2024).
Is there a generic or store brand of BYNFEZIA Pen?: Other products of Octreotide acetate are listed with the FDA, but none in exactly the same strength and form as a BYNFEZIA Pen product.
Has BYNFEZIA Pen been recalled?: No recall linked to BYNFEZIA Pen products (by their NDC code or label) appears in the FDA enforcement reports we use.

What BYNFEZIA Pen is

Each BYNFEZIA Pen 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.

Octreotide acetate · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
octreotide acetate 2.5 mg/mL injection (subcutaneous)	BYNFEZIA Pen	None listed	DailyMed

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

FDA approval

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

FDA applications of BYNFEZIA Pen products (Drugs@FDA)
Application	Holder	First approved	Products
NDA213224	Sun Pharm	September 27, 2024	1

Companies that list BYNFEZIA Pen

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

Sun Pharmaceutical Industries, Inc.1 product

Recalls

No recall linked to BYNFEZIA Pen 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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BYNFEZIA Pen