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ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL Suspension/ Drops — NDC 00713-0851-09 package photo

ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL Suspension/ Drops

by Cosette Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE
NDC 00713-0851-09
🏷️ FDA NDC (as labeled) 0713-0851-09 billing pads the labeler segment with a zero
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0713-0851-09
Product NDC 0713-0851
11-digit billing NDC 00713085109
NCPDP billing unit ML — per mL (volume)
RxCUI 309305
UNII 4BA73M5E37, WI4X0X7BPJ
Application # ANDA218273
SPL Set ID 6848cb55-7ca4-40ca-9751-f1fc262b8336
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-04
Route AURICULAR (OTIC)
Dosage form SUSPENSION/ DROPS
Substance CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
GPI-14 87991002401820
GCN Seq No 039806
GCN 82031
HICL code 018392
Ingredient (HICL) Ciprofloxacin/Hydrocortisone
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q8
Therapeutic class — intermediate (HIC2) Otic Preparations
HIC3 code Q8F
Therapeutic class — specific (HIC3) Otic Preparations,Anti-Inflammatory-Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name CIPROFLOXACIN-HYDROCORT 0.2-1%
FDB brand name Ciprofloxacin-Hydrocortisone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0713-0851-09 — a 4-4-2 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 labeler segment → 00713-0851-09. 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

LabelerCosette Pharmaceuticals, Inc.
Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC
FDA applicationANDA218273 (ANDA)
Labeler code00713
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio99 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-HYDROCORT 0.2-1% Ingredient Ciprofloxacin/Hydrocortisone
📖 What it is MedlinePlus · NLM

Ciprofloxacin and hydrocortisone otic is used to treat outer ear infections in adults and children. Ciprofloxacin is in a class of medications called quinolone antibiotics. Hydrocortisone is in a class of medications called corticosteroids. The combination of ciprofloxacin and hydrocortisone works by killing the bacteria that cause infection and reducing swelling in the ear.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's treating swimmer's ear — the medical name is acute otitis externa. That's an infection of the outer ear canal, not the middle ear. The ciprofloxacin in the drops kills the bac...
  • Putting cold liquid into your ear canal can trigger dizziness. It only takes a minute or two — just hold the bottle in your hand to bring it closer to body temperature before you p...
  • Why do I need to warm the bottle before using it?
  • First, shake the bottle well, then warm it in your hand for a couple of minutes. Lie down so the affected ear is facing up. After you put the drops in, stay in that position for ab...
📖 Read our full Ciprofloxacin / Hydrocortisone 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.

💡 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 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 DailyMed — ingredient 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 $26.796 $267.96 / 10 ml
Medicaid paysCMS SDUD · 12 mo $32.02 $320.25 / 10 ml
Medicare drug plans payPart D · Q2 2026 $29.96 $299.65 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Apr 2026 May 2026 Jun 2026 Aug 2026 $29.100 $26.796
▼ Down 8% over the last 5 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 and hydrocortisone 2 mg/mL; 10 mg/mLthis 00713-0851-09 Cosette 1 bottle $26.796 AB Availability likely —
Cipro Hc 2 mg/mL; 10 mg/mL 66758-0087-70 Sandoz 1 bottle $34.868 AB Availability likely +30%
Cipro Hc 2 mg/mL; 10 mg/mL 50090-6043-00 A-S 10 ml — AB FDA listed —
Cipro Hc 2 mg/mL; 10 mg/mL 50090-7631-00 A-S 1 bottle — AB FDA listed —
Cipro Hc 2 mg/mL; 10 mg/mL 76420-0273-10 Asclemed 10 ml — AB FDA listed —
ciprofloxacin hydrochloride and hydrocortisone 2 mg/mL; 10 mg/mL 00781-6218-70 Sandoz 1 bottle — AB 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

🏛️
2025
First FDA approval
Nov 2025
📍
2026
Currently FDA-listed
1 year 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.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jun 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.
📅 FDA approved Nov 10, 2025 AB TE-rated RLD RS

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity CGT
2025
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
CGTFDA-granted marketing exclusivityJun 2, 2026
Common questions
Is there a generic version of CIPROFLOXACIN-HYDROCORT 0.2-1%?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for CIPROFLOXACIN-HYDROCORT 0.2-1%. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 00713-0851-09, 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.
📅 Q4 2025 – Q4 2025 · 1 quarter 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
64
Units reimbursed last 4 qtrs
640
Gross reimbursed last 4 qtrs
$20.5K
Avg / prescription
$320.24
Avg / unit
$32.0245
Latest quarter Q4 2025
64Rx
Medicaid pays / mL
$32.0245
gross reimbursed
vs
NADAC / mL
$26.7962
acquisition cost
=
Spread
+$5.2283
+20% 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 ⓘ
22% FFS 78% MCO
Fee-for-service · 14 Rx Managed care · 50 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 190 units · 2.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 450 units · 11.1 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.411.1
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 Oklahoma 11.1 /100k
2 Washington 2.4 /100k
💵 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.

🔬 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 hydrochloride and hydrocortisone — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity2,483
Pain1,607
Neuropathy Peripheral1,440
Nausea1,411
Diarrhoea1,397
Arthralgia1,374
Fatigue1,324

Reporter sex

20,675 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,027
Death1,433
Disabling1,377
Life-threatening618
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,842 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
00713-0851-09 You're viewing this 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE 2025-12-04 Active

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 42 words ▾

INDICATIONS AND USAGE Ciprofloxacin hydrochloride and hydrocortisone otic suspension is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .

⏱️ Dosage and Administration 114 words ▾

DOSAGE AND ADMINISTRATION SHAKE WELL IMMEDIATELY BEFORE USING. For children (age 1 year and older) and adults, 3 drops of the suspension should be instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for 1-2 minutes to avoid the dizziness which may result from the instillation of a cold solution into the ear canal.

The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 30-60 seconds to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.

Discard unused portion after therapy is completed.

⛔ Contraindications 66 words ▾

CONTRAINDICATIONS Ciprofloxacin hydrochloride and hydrocortisone otic suspension is contraindicated in persons with a history of hypersensitivity to hydrocortisone, ciprofloxacin or any member of the quinolone class of antimicrobial agents. This nonsterile product should not be used if the tympanic membrane is known or suspected to be perforated. Use of this product is contraindicated in viral infections of the external canal including varicella and herpes simplex infections.

⚠️ Warnings 73 words ▾

WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Ciprofloxacin hydrochloride and hydrocortisone otic suspension should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment. The dropper cap contains natural rubber (latex) which may cause severe allergic reactions.

🤒 Adverse Reactions 155 words ▾

ADVERSE REACTIONS In Phase 3 clinical trials, a total of 564 patients were treated with ciprofloxacin hydrochloride and hydrocortisone otic suspension. Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%). The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia.

The following reactions have been identified during post-approval use of ciprofloxacin hydrochloride and hydrocortisone otic suspension in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ciprofloxacin hydrochloride and hydrocortisone otic suspension, or a combination of these factors include: dizziness, ear canal erythema, ear congestion, hypoacusis and medication residue.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 170 words ▾

Pregnancy: Teratogenic Effects: Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with ciprofloxacin hydrochloride and hydrocortisone otic suspension.

No adequate and well controlled studies have been performed in pregnant women. Caution should be exercised when ciprofloxacin hydrochloride and hydrocortisone otic suspension is used by a pregnant woman.

🧒 Pediatric Use 51 words ▾

Pediatric use: The safety and efficacy of ciprofloxacin hydrochloride and hydrocortisone otic suspension have been established in pediatric patients 2 years and older (131 patients) in adequate and well-controlled clinical trials. Efficacy has been extrapolated for patients, age 1 year and above based on studies in adults and older pediatric patients.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY The plasma concentrations of ciprofloxacin were not measured following three drops of otic suspension administration because the systemic exposure to ciprofloxacin is expected to be below the limit of quantitation of the assay (0.05 μg/mL). Similarly, the predicted C max of hydrocortisone is within the range of endogenous hydrocortisone concentration (0-150 ng/mL), and therefore can not be differentiated from the endogenous cortisol. Preclinical studies have shown that ciprofloxacin hydrochloride and hydrocortisone otic suspension was not toxic to the guinea pig cochlea when administered intratympanically twice daily for 30 days and was only weakly irritating to rabbit skin upon repeated exposure.

Hydrocortisone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection. Microbiology Ciprofloxacin has in vitro activity against a wide range of gram-positive and gram-negative microorganisms. The bactericidal action of ciprofloxacin results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA.

Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections of acute otitis externa as described in the INDICATIONS AND USAGE section: Aerobic gram-positive microorganism Staphylococcus aureus Aerobic gram-negative microorganisms Proteus mirabilis Pseudomonas aeruginosa

📦 How Supplied / Storage and Handling 69 words ▾

HOW SUPPLIED Ciprofloxacin hydrochloride and hydrocortisone otic suspension is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser: NDC 0713-0851-09 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Protect from light.

Distributed by: Cosette Pharmaceuticals NC Laboratories, LLC Lincolnton, NC 28092 8-0851CPLNC1 Revised: 02/2025 VC7789

📋 Description 153 words ▾

DESCRIPTION Ciprofloxacin hydrochloride and hydrocortisone otic suspension contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each mL of ciprofloxacin hydrochloride and hydrocortisone otic suspension contains ciprofloxacin hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg hydrocortisone, and 9 mg benzyl alcohol as a preservative. The inactive ingredients are glacial acetic acid, phospholipon 90H (modified lecithin), polysorbate, polyvinyl alcohol, purified water, sodium acetate, and sodium chloride.

Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a fluoroquinolone, is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17 H 18 FN 3 O 3 •HCI•H 2 O and its chemical structure is as follows: Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11β)-, is an anti-inflammatory corticosteroid.

Its empirical formula is C 21 H 30 O 5 and its chemical structure is: Ciprofloxacin Hydrocortisone

💬 Information for Patients 50 words ▾

Information for Patients: If rash or allergic reaction occurs, discontinue use immediately and contact your physician. Do not use in the eyes. Avoid contaminating the dropper with material from the ear, fingers, or other sources. Protect from light. Shake well immediately before using. Discard unused portion after therapy is completed.

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