HomeNDC LookupIngredientsCiprofloxacin › 69315-0308-05
ciprofloxacin 3 mg/mL Solution — NDC 69315-0308-05 package photo

ciprofloxacin 3 mg/mL Solution

by Leading Pharma, LLC · 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05) / 5 mL in 1 BOTTLE, PLASTIC
NDC 69315-0308-05
🏷️ FDA NDC (as labeled) 69315-308-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, plastic Cost per mL$1.55 NADAC Per package$7.73 / 5 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $2.46/unit · Part D plans $2.57/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🚨
Active recall for this product.
Class II · Mar 11, 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 (FDC Limited) · FDA recall D-0282-2025
Class II · Dec 16, 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 (FDC Limited) · FDA recall D-0182-2025
Class II · Jul 23, 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. (FDC Limited) · FDA recall D-0623-2024
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 69315-308-05
Product NDC 69315-308
11-digit billing NDC 69315030805
NCPDP billing unit ML — per mL (volume)
RxCUI 309307
UNII 4BA73M5E37
UPC 0369315308028, 0369315308059
Application # ANDA077568
SPL Set ID 545527e7-05c7-4dbf-ab32-b3fa463d55b0
Established class (EPC) Fluoroquinolone Antibacterial
Mechanism of action Cytochrome P450 1A2 Inhibitors
Chemical class Fluoroquinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-01
Route OPHTHALMIC
Dosage form SOLUTION
Substance CIPROFLOXACIN HYDROCHLORIDE
GPI-14 86101023102010
GPI class Ciprofloxacin HCl
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 69315-308-05 — 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 → 69315-0308-05. 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.

🏷️ RxNorm drug class

This medicine belongs to the Fluoroquinolone Antibacterial class.

Pharmacologic class Fluoroquinolone Antibacterial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives
How it works Cytochrome P450 1A2 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLeading Pharma, LLC
Application holderFDC LTD
FDA applicationANDA077568 (ANDA)
Labeler code69315
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio83 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
📖 What it is MedlinePlus · NLM

Ciprofloxacin ophthalmic solution is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of the membrane that covers the outside of the eyeball and the inside of the eyelid) and corneal ulcers (infection and loss of tissue in the clear front part of the eye). Ciprofloxacin ophthalmic ointment is used to treat conjunctivitis. Ciprofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infection.

Read the full MedlinePlus article ↗
📗 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 →
11
Nutrient depletion considerations

Ciprofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII NVG71ZZ7P0
    A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $1.547 $7.73 / 5 ml
Medicaid paysCMS SDUD · 12 mo $2.46 $12.31 / 5 ml
Medicare drug plans payPart D · Q2 2026 $2.57 $12.86 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $2.180 $1.547
▼ Down 26% over the last 24 months.
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/mLthis 69315-0308-05 Leading 1 bottle $1.546 AT Availability likely
Ciprofloxacin Hydrochloride 3 mg/mL 72888-0102-21 Advagen 2.5 ml $3.202 AT Availability likely +107%
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/mL 85534-0075-00 HAWAII 1 bottle AT FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69315-0308-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
71.7K
Units reimbursed last 4 qtrs
411.4K
Gross reimbursed last 4 qtrs
$1.01M
Avg / prescription
$14.12
Avg / unit
$2.4615
Latest quarter Q4 2025
15.3KRx
Medicaid pays / mL
$2.4615
gross reimbursed
vs
NADAC / mL
$1.5465
acquisition cost
=
Spread
+$0.9150
+59% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
34% FFS 66% MCO
Fee-for-service · 24,027 Rx Managed care · 47,680 Rx
State Medicaid map
Alaska: 715 units · 97.5 per 100k residents AK Maine: 905 units · 64.9 per 100k residents ME Washington: 4,365 units · 55.9 per 100k residents WA Idaho: 2,600 units · 132 per 100k residents ID Montana: 1,748 units · 154 per 100k residents MT North Dakota: 1,696 units · 217 per 100k residents ND Minnesota: 4,185 units · 72.9 per 100k residents MN Wisconsin: 3,855 units · 65.2 per 100k residents WI Michigan: 12,018 units · 120 per 100k residents MI New York: 22,294 units · 114 per 100k residents NY Vermont: 170 units · 26.3 per 100k residents VT New Hampshire: 505 units · 36.0 per 100k residents NH Oregon: 4,040 units · 95.4 per 100k residents OR Nevada: 3,583 units · 112 per 100k residents NV Wyoming: 80 units · 13.7 per 100k residents WY South Dakota: 760 units · 82.7 per 100k residents SD Iowa: 6,803 units · 212 per 100k residents IA Illinois: 9,963 units · 79.4 per 100k residents IL Indiana: 14,241 units · 208 per 100k residents IN Ohio: 26,300 units · 223 per 100k residents OH Pennsylvania: 14,150 units · 109 per 100k residents PA New Jersey: 11,385 units · 123 per 100k residents NJ Massachusetts: 7,189 units · 103 per 100k residents MA California: 65,368 units · 168 per 100k residents CA Utah: 5,855 units · 171 per 100k residents UT Colorado: 3,056 units · 52.0 per 100k residents CO Nebraska: 2,286 units · 116 per 100k residents NE Missouri: 6,420 units · 104 per 100k residents MO Kentucky: 6,927 units · 153 per 100k residents KY West Virginia: 1,160 units · 65.5 per 100k residents WV Virginia: 8,945 units · 103 per 100k residents VA Maryland: 6,378 units · 103 per 100k residents MD Connecticut: 3,770 units · 104 per 100k residents CT Rhode Island: 965 units · 88.1 per 100k residents RI Arizona: 12,286 units · 165 per 100k residents AZ New Mexico: 4,635 units · 219 per 100k residents NM Kansas: 2,740 units · 93.2 per 100k residents KS Arkansas: 1,920 units · 62.6 per 100k residents AR Tennessee: 4,221 units · 59.2 per 100k residents TN North Carolina: 11,343 units · 105 per 100k residents NC South Carolina: 7,172 units · 133 per 100k residents SC Delaware: 755 units · 73.2 per 100k residents DE Oklahoma: 4,978 units · 123 per 100k residents OK Louisiana: 7,135 units · 156 per 100k residents LA Mississippi: 3,446 units · 117 per 100k residents MS Alabama: 2,923 units · 57.2 per 100k residents AL Georgia: 28,698 units · 260 per 100k residents GA D.C.: 606 units · 89.2 per 100k residents DC Hawaii: 1,544 units · 108 per 100k residents HI Texas: 19,160 units · 62.8 per 100k residents TX Florida: 29,848 units · 132 per 100k residents FL
Units reimbursed · per 100k residents
13.7260
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Georgia 260 /100k
2 Ohio 223 /100k
3 New Mexico 219 /100k
4 North Dakota 217 /100k
5 Iowa 212 /100k
6 Indiana 208 /100k
7 Utah 171 /100k
8 California 168 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page69315-0308-05 71,707 Rx · $1,012,636
1 bottle69315-0308-02 9,019 Rx · $103,631
1 bottle69315-0308-10 7,325 Rx · $140,562
Drug total (last 4 qtrs): 88,051 Rx · 511,086 units · $1,256,830 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cipro (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cipro. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$92.9K
Claims incl. refills
550
Beneficiaries
474
Spend / beneficiary
$196.00
Spend / claim
$168.91
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
69315-0308-02 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-02) / 2.5 mL in 1 BOTTLE, PLASTIC $3.20 / mL $8.00 2018-11-01 Active
69315-0308-05 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05) / 5 mL in 1 BOTTLE, PLASTIC $1.55 / mL $7.73 2018-11-01 Active
69315-0308-10 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-10) / 10 mL in 1 BOTTLE, PLASTIC $0.7990 / mL $7.99 2018-11-01 Active

Per mL, this pack runs about 94% above the cheapest pack (NDC 69315-0308-10, $0.7990 vs $1.55 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69315-0308-05?
NDC 69315-0308-05 is listed by the FDA — 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of ciprofloxacin 3 mg/mL Solution?
Bill NDC 69315-0308-05 — the 11-digit billing format is 69315030805. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 63 words

INDICATIONS AND USAGE 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 135 words

DOSAGE AND ADMINISTRATION 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-epithelialisation 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.

Contraindications 34 words

CONTRAINDICATIONS 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 and Cautions 90 words

WARNINGS 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 105 words

ADVERSE REACTIONS 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, contact LEADING PHARMA AT 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 61 words

Drug Interactions: Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

🧒 Pediatric Use 90 words

Pediatric Use: The safety and effectiveness of Ciprofloxacin ophthalmic solution 0.3% have been established in all ages. Use of Ciprofloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of Ciprofloxacin ophthalmic solution in adults, children and neonates [ see Clinical Studies ]. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.

🧓 Geriatric Use 17 words

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🆘 Overdosage 19 words

OVERDOSAGE A topical overdose of Ciprofloxacin ophthalmic solution 0.3% may be flushed from the eye(s) with warm tap water.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Systemic Absorption: A systemic absorption study was performed in which Ciprofloxacin ophthalmic solution 0.3% 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 organisms both in vitro and in clinical infections ( see INDICATIONS AND USAGE ).

Aerobic gram-Positive microorganisms: Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus pneumoniae Streptococcus (Viridans Group) Aerobic gram-negative microorganisms: 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 subsp. anitratus Aeromonas caviae Aeromonas hydrophila Brucella melitensis Campylobacter coli Campylobacter jejuni Citrobacter diversus Citrobacter freundii Edwardsiella tarda Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus ducreyi Haemophilus parainfluenzae Kiebsiella pneumoniae Klebsiella oxytoca Legionella pneumophila Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria gonorrhoeae Neisseria meningitides Pasteurella multocida Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella enteritidis Salmonella typhi Shigella sonneii Shigella flexneri Vibrio cholera Vibrio parahaemolyticus Vibrio vulnificus 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.

📦 How Supplied / Storage and Handling ~3 min read

HOW SUPPLIED As a sterile ophthalmic solution: 2.5 mL, 5 mL and 10 mL in translucent LDPE bottle with insert cap assembly comprising of a tan colored HDPE screw cap over a LDPE nozzle with tamper evident LDPE dust cover sealing the bottle cap. 2.5 mL - NDC 69315-308-02 5 mL – NDC 69315-308-05 10 mL – NDC 69315-308-10 STORAGE: Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Retain in carton until contents are used and protect from light.

ANIMAL PHARMACOLOGY: Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions. CLINICAL STUDIES: Following therapy with Ciprofloxacin ophthalmic solution 0.3%, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialisation 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. In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis, between birth and 31 days of age, patients were dosed with Ciprofloxacin ophthalmic solution or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 85% at Day 9.

Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials. Rx Only Distributed by: Leading Pharma, LLC. Fairfield, NJ07004 Manufactured By: FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad - 431 136, Maharashtra, India Revision: 10/2019 STERILE OPHTHALMIC SOLUTION CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% INSTRUCTIONS FOR USE Read this Instruction for Use before you start using Ciprofloxacin ophthalmic solution and each time you get a refill.

There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Use Ciprofloxacin ophthalmic solution as prescribed by your doctor.

Ask your doctor if you have questions about how to use Ciprofloxacin ophthalmic solution. Important information: Ciprofloxacin ophthalmic solution is for use in the eye only. Ciprofloxacin ophthalmic solution should not be injected into the eye.

If you use other medicines in your eye, wait at least 10 minutes between using Ciprofloxacin ophthalmic solution and your other eye medicines. If you wear contact lenses, remove them before using Ciprofloxacin ophthalmic solution. Wait at least 15 minutes after using Ciprofloxacin ophthalmic solution before placing your contact lenses back in your eyes.

Do not touch your eye, fingers, or other surfaces with the tip of the Ciprofloxacin ophthalmic solution bottle. You may get bacteria on the tip of the bottle that can cause you to get an eye infection. This eye infection can lead to serious eye damage or vision loss.

If you think you have gotten bacteria on the tip of the bottle or you have an eye infection, call your doctor right away. Wash your hands before each use. Before you use a bottle of Ciprofloxacin ophthalmic solution for the first time: Check the expiration date on the bottle before use.

Do not use Ciprofloxacin ophthalmic solution if the expiration date has passed. Check that the seal on the dust cover is not broken or missing. Do not use the medicine if the seal is broken or missing.

Call your doctor or pharmacist. Each time you use Ciprofloxacin ophthalmic solution: Step 1: Turn the dust cover clockwise to break the seal. Step 2: Remove the dust cover and throw it away.

Step 3: Turn the tan coloured cap anti-clockwise and remove. Place the cap on a…

📋 Description 166 words

DESCRIPTION Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic 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 C 17 H 18 FN 3 O 3 •HCl•H 2 O 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 0.3% 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.

Ciprofloxacin hydrochloride

💬 Information for Patients 17 words

Information for patients: Do not touch dropper tip to any surface, as this may contaminate the solution.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.