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Brand-name prescription medicine

Gentamicin Sulfate Opth Solution

Generic name: Gentamicin sulfate

FDA application holder: Bausch and Lomb Inc

Strengths and generic versions Official label

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.

At a glance

1Strengths and forms
10Same medicine, other names
1994FDA approval
0Recalls (FDA reports)

Quick answers

What is Gentamicin Sulfate Opth Solution?
Gentamicin Sulfate Opth Solution is a brand name of Gentamicin sulfate, a prescription medicine. The FDA NDC Directory lists 1 Gentamicin Sulfate Opth Solution product in 1 strength and form.
Who makes Gentamicin Sulfate Opth Solution?
Bausch and Lomb Inc holds the FDA application for Gentamicin Sulfate Opth Solution (ANDA064048, approved May 11, 1994).
Is there a generic or store brand of Gentamicin Sulfate Opth Solution?
Yes. The FDA NDC Directory lists 10 other products with the same active ingredients, strength and form as a Gentamicin Sulfate Opth Solution product, 10 of them generic. Ask your pharmacist whether one is right for you.
Has Gentamicin Sulfate Opth Solution been recalled?
No recall linked to Gentamicin Sulfate Opth Solution products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Gentamicin Sulfate Opth Solution is

Each Gentamicin Sulfate Opth Solution 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.

Gentamicin sulfate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
gentamicin sulfate 3 mg/mL
solution/ drops (ophthalmic)		 Gentamicin Sulfate Opth Solution 10 products, 7 companies DailyMed

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

FDA approval

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
FDA applications of Gentamicin Sulfate Opth Solution products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
ANDA064048Bausch and Lomb IncMay 11, 19941

Companies that list Gentamicin Sulfate Opth Solution

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

Recalls

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

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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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