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CIPROFLOXACIN 3 mg/mL Solution/ Drops, 5 mL

by DIRECT RX · 5 mL in 1 BOTTLE (61919-491-05)
NDC 61919-0491-05
🏷️ FDA NDC (as labeled) 61919-491-05 billing pads the product segment with a zero
This package
Contains5 mL Pack sizes3 compare ↓
Also comes in: 1 ml 61919-0491-25 1 ml 61919-0491-50
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-491-05
Product NDC 61919-491
11-digit billing NDC 61919049105
NCPDP billing unit ML — per mL (volume)
Application # NDA019992
SPL Set ID 0fa41584-2f85-4ed9-9042-a713cd7ecc59
Chemical class Quinolone Antimicrobial [EPC], Quinolones
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance CIPROFLOXACIN HYDROCHLORIDE
GCN Seq No 015861
GCN 33580
HICL code 004124
Ingredient (HICL) Ciprofloxacin Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name CIPROFLOXACIN 0.3% EYE DROP
FDB brand name Ciprofloxacin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 61919-491-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61919-0491-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerDIRECT RX
Application holderSANDOZ INC
FDA applicationNDA019992 (NDA)
Labeler code61919
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CIPROFLOXACIN 0.3% EYE DROP Ingredient Ciprofloxacin Hcl
📗 Our plain-language guide HelloPharmacist
  • Ciprofloxacin treats a wide range of bacterial infections — things like urinary tract infections, skin infections, bone and joint infections, infectious diarrhea, typhoid fever, an...
  • What kinds of infections does ciprofloxacin actually treat?
  • You can take ciprofloxacin with or without food — that part's flexible. But avoid taking it at the same time as milk, yogurt, or calcium-fortified juices, because dairy and calcium...
  • The most common side effects are nausea, diarrhea, and vomiting — uncomfortable, but usually manageable. The ones that mean stop-and-call-your-doctor-now are tendon pain (especiall...
📖 Read our full Ciprofloxacin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 ml 1 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciprofloxacin Hydrochloride 3 mg/mL 61314-0656-05 Sandoz 1 bottle $1.546 AT Availability likely —
ciprofloxacin 3 mg/mL 69315-0308-02 Leading 1 bottle $3.202 AT Availability likely —
Ciprofloxacin Hydrochloride 3 mg/mL 72888-0102-21 Advagen 2.5 ml $3.202 AT Availability likely —
Ciprofloxacin Hydrochloride 3 mg/mL 50090-0882-00 A-S 1 bottle — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 50090-1754-00 A-S 1 bottle — AT FDA listed —
ciprofloxacin 3 mg/mL 50090-4217-00 A-S 1 bottle — AT FDA listed —
Ciprofloxacin HCl Ophthalmic 3 mg/mL 59390-0217-02 Altaire 2.5 ml — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 63187-0985-05 Proficient 1 bottle — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 67296-0142-01 Redpharm 1 bottle — AT FDA listed —
ciprofloxacin 3 mg/mL 67296-1703-09 Redpharm 2 bottles — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 68071-3351-03 NuCare 10 ml — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 68071-4139-05 NuCare 5 ml — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 68071-4235-03 NuCare 2.5 ml — AT FDA listed —
ciprofloxacin 3 mg/mL 68071-4672-03 NuCare 2.5 ml — AT FDA listed —
ciprofloxacin 3 mg/mL 68071-4679-05 NuCare 5 ml — AT FDA listed —
ciprofloxacin 3 mg/mL 68788-7500-05 Preferred 1 bottle — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 68788-8198-05 Preferred 1 bottle — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 70518-1170-00 REMEDYREPACK 1 bottle — AT FDA listed —
ciprofloxacin 3 mg/mL 71205-0300-05 Proficient 1 bottle — AT FDA listed —
ciprofloxacin 3 mg/mL 76420-0588-02 Asclemed 1 bottle — AT FDA listed —
Ciprofloxacin Hydrochloride 3 mg/mL 76420-0942-03 Asclemed 1 bottle — AT FDA listed —
ciprofloxacin 3 mg/mL 80425-0499-01 Advanced 1 bottle — AT FDA listed —
ciprofloxacin 3 mg/mL 85766-0023-05 Sportpharm 1 bottle — AT FDA listed —
Ciprofloxacin 3 mg/mLthis 61919-0491-05 DIRECT 5 ml — AT Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ciprofloxacin (this brand).

Top reported reactions

Fatigue4,781
Pain4,648
Nausea4,607
Diarrhoea4,587
Acute Kidney Injury4,360
Arthralgia4,330
Chronic Kidney Disease4,106

Age at onset

Neonate88
Infant94
Child288
Adolescent239
Adult6,774
Elderly4,290

Reporter sex

76,395 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization31,671
Death8,309
Disabling5,604
Life-threatening5,260
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,225 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0491-05 You're viewing this 5 mL in 1 BOTTLE (61919-491-05) 2018-03-15 Inactivated by FDA
61919-0491-25 1 mL in 1 BOTTLE (61919-491-25) 2018-03-15 Inactivated by FDA
61919-0491-50 1 mL in 1 BOTTLE (61919-491-50) 2018-03-15 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 61919-0491-05?
NDC 61919-0491-05 contains 5 mL — 5 ml in 1 bottle.
What is the difference between NDC 61919-0491-05 and NDC 61919-0491-25?
Both are CIPROFLOXACIN 3 mg/mL Solution/ Drops — the drug itself is identical. NDC 61919-0491-05 is the 5 mL package, while NDC 61919-0491-25 is the 1 ml package.
What NDC number is used to bill for this package of CIPROFLOXACIN 3 mg/mL Solution/ Drops?
Bill NDC 61919-0491-05 — the 11-digit billing format is 61919049105. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61919-491-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61919-0491-05, written without dashes as 61919049105. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61919-0491-05, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0491) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 ml (61919-0491-25), 1 ml (61919-0491-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
DIRECT RX is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📋 Description
🎯 Indications and Usage 65 words ▾

INDICATIONS & USAGE SECTION Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) * Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae * Efficacy for this organism was studied in fewer than 10 infections.

⏱️ Dosage and Administration 181 words ▾

DOSAGE & ADMINISTRATION SECTION Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours.

Treatment may be continued after 14 days if corneal re-epithelialization has not occurred. Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days. How Supplied: As a sterile ophthalmic solution, in a plastic dispenser: 2.5 mL NDC16571-120-25 5 mL NDC16571-120-50 STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature].

Protect from light. Retain in carton until contents are used.

⛔ Contraindications 35 words ▾

CONTRAINDICATIONS SECTION A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.

⚠️ Warnings 91 words ▾

WARNINGS SECTION NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.

Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Remove contact lenses before using.

🤒 Adverse Reactions 104 words ▾

ADVERSE REACTIONS SECTION The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients (SEE PRECAUTIONS ). Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation.

Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision. to report suspected adverse reactions call 1-800-332-1088 to report suspected adverse reactions call 1-800-332-1088

🆘 Overdosage 19 words ▾

OVERDOSAGE SECTION A topical overdose of Ciprofloxacin Ophthalmic Solution may be flushed from the eye(s) with warm tap water.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY SECTION Systemic Absorption: A systemic absorption study was performed in which Ciprofloxacin Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually less than 2.5 ng/mL.

Microbiology: Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA. Ciprofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections (SEE INDICATIONS AND USAGE section): Gram-Positive: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) Gram-Negative: Haemophilus influenzae Pseudomonas aeruginosa Serratia marcescens Ciprofloxacin has been shown to be active in vitro against most strains of the following organisms, however, the clinical significance of these data is unknown: Gram-Positive: Enterococcus faecalis (Many strains are only moderately susceptible) Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus Streptococcus pyogenes Gram-Negative Acinetobacter calcoaceticus Escherichia coli Proteus mirabilis subsp. anitratus Haemophilus ducreyi Proteus vulgaris Aeromonas caviae Haemophilus parainfluenzae Providencia rettgeri Aeromonas hydrophila Kiebsiella pneumoniae Providencia stuartii Brucella melitensis Kiebsiella oxytoca Salmonella enteritidis Campylobacter coli Legionella pneumophila Salmonella typhi Campylobacter jejuni Moraxella (Branhamella) Shigella sonneii Citrobacter diversus catarrhalis Shigella flexneri Citrobacter freundii Morganella morganii Vibrio cholerae Edwardsiella tarda Neisseria gonorrhoeae Vibrio parahaemolyticus Enterobacter aerogenes Neisseria meningitidis Vibrio vulnificus Enterobacter cloacae Pasteurella multocida Yersinia enterocolitica Other Organisms: Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible).

Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile. The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation).

Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin. Clinical Studies: Following therapy with Ciprofloxacin Ophthalmic Solution, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization occurred in about 92% of the ulcers. In 3 and 7 day multicenter clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment.

📋 Description 155 words ▾

DESCRIPTION SECTION Ciprofloxacin Ophthalmic Solution is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid.

It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin Ophthalmic Solution contains: Active: Ciprofloxacin HCl 3.5 mg equivalent to 3 mg base.

Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm. image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61919-0484-18 · Direct_Rx 61919-0493-03 · Direct →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.