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Prescription medicine · generic available

Ciprofloxacin

Brand names: Ciprofloxacin in Dextrose, Cipro, Ciloxan

Also listed by the FDA as: ciprofloxacin hydrochloride · ciprofloxacin

Drug class: Fluoroquinolone Antibacterial

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

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

YesBoxed warning
None listedFDA shortage list
9Recalls (FDA reports)
49Companies
1987First FDA approval on file

Quick answers

What is Ciprofloxacin used for?
The FDA-approved label (Cipro, Bayer HealthCare Pharmaceuticals Inc., March 2, 2026) says: “CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ciprofloxacin have a boxed warning?
Yes. The FDA label for Cipro has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Ciprofloxacin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ciprofloxacin been recalled?
FDA enforcement reports list 9 recalls of products of this medicine; the newest started March 11, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Ciprofloxacin?
49 companies list prescription products of Ciprofloxacin in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and PD-Rx Pharmaceuticals, Inc..

What Ciprofloxacin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated …

— FDA label: Cipro, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026. Read the full label on DailyMed →

The FDA has 160 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Pneumonia

Related medical specialties

Infectious Disease

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

132 of 160 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Tablet, coated · Solution · Solution/ drops · Injection, solution · Ointment
RouteOral · Ophthalmic · Intravenous · Auricular (otic)
Prescription products201 in the FDA NDC Directory
Brand namesCiprofloxacin in Dextrose, Cipro, Ciloxan

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ciprofloxacin, by strength and form
Strength and formGeneric or brandPharmacies pay
ciprofloxacin 0.5 mg/0.25 mL
solution/ drops		 Generic $6.50 per unit
ciprofloxacin hydrochloride 0.3%
ointment		 Brand: Ciloxan $74.36 per gram
ciprofloxacin hydrochloride 250 mg
tablet		 Generic $0.0804 per tablet
ciprofloxacin hydrochloride 250 mg
tablet, film coated		 Generic $0.0804 per tablet
ciprofloxacin hydrochloride 3 mg/mL
solution		 Generic $0.8741–$2.90 per mL
6 packages, lowest to highest
ciprofloxacin hydrochloride 3 mg/mL
solution/ drops		 Generic $0.8741–$2.90 per mL
3 packages, lowest to highest
ciprofloxacin hydrochloride 500 mg
tablet		 Generic $0.1206 per tablet
ciprofloxacin hydrochloride 500 mg
tablet, film coated		 Generic $0.1206 per tablet
ciprofloxacin hydrochloride 750 mg
tablet, film coated		 Generic $0.2450 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA019537
CIPRO		 Bayer HlthcareOctober 22, 1987 55, latest September 20, 2024
2024: Labeling · 2021: Labeling · 2021: Labeling
NDA019992
CILOXAN		 SandozDecember 31, 1990 19, latest March 21, 2017
2017: Labeling · 2006: Labeling · 2004: Labeling
NDA020369
CILOXAN		 SandozMarch 30, 1998 12, latest February 17, 2017
2017: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC)

Generic approvals (14)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. March 11, 2025 · Class II · Ongoing · D-0282-2025

    Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 — FDC Limited

  2. December 16, 2024 · Class II · Ongoing · D-0182-2025

    Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 — FDC Limited

  3. July 23, 2024 · Class II · Ongoing · D-0623-2024

    Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

    Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited — FDC Limited

  4. April 13, 2022 · Class II · Terminated · D-1044-2022

    cGMP deviations: Temperature abuse

    Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05 — Mckesson Medical-Surgical Inc. Corporate Office

  5. July 2, 2019 · Class II · Completed · D-0419-2020

    Lack of Assurance of Sterility

    Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02 — Altaire Pharmaceuticals, Inc.

  6. July 2, 2019 · Class II · Completed · D-0420-2020

    Lack of Assurance of Sterility

    Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10 — Altaire Pharmaceuticals, Inc.

  7. July 2, 2019 · Class II · Completed · D-0478-2020

    Lack of Assurance of Sterility

    Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05 — Altaire Pharmaceuticals, Inc.

  8. February 6, 2013 · Class II · Terminated · D-220-2013

    Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.

    Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01 — West-ward Pharmaceutical Corp.

  9. March 9, 2012 · Class III · Terminated · D-1422-2012

    Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.

    Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: P — Pack Pharmaceuticals

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197511, 197512, 205769, 205770, 213224, 213226, 213307, 309306, 309307, 309308 … (+4)
SPL set ID of the quoted label888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0
FDA labels (SPL)160
FDA applicationsNDA019537, NDA019992, NDA020369, 14 ANDA
Active ingredients (FDA)CIPROFLOXACIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cipro, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (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. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers