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Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops, 1 bottle — NDC 53746-831-53 (Billing 53746-0831-53)

by Amneal Pharmaceuticals of New York LLC · 1 BOTTLE, PLASTIC in 1 CARTON / 7.5 mL in 1 BOTTLE, PLASTIC

This is a package of 1 bottle of Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops from Amneal Pharmaceuticals of New York LLC, marketed since Mar 2024 and currently FDA-listed; retail pharmacies pay about $7.12 per mL (NADAC). It is this product's only package size.

NDC 53746-0831-53
🏷️ FDA NDC (as labeled) 53746-831-53 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Other active recalls for Ciprofloxacin And Dexamethasone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 13, 2025 — Temperature Abuse (Sandoz Inc) · FDA recall D-0626-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53746-831-53
Product NDC 53746-831
11-digit billing NDC 53746083153
NCPDP billing unit ML — per mL (volume)
RxCUI 403908
UNII 4BA73M5E37, 7S5I7G3JQL
Application # ANDA216501
SPL Set ID 55426495-5fd1-44ca-afcc-ffbbb0a0a569
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 2024-03-26
Route AURICULAR (OTIC)
Dosage form SUSPENSION/ DROPS
Substance CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 87991002361820
GCN Seq No 052911
GCN 20188
HICL code 025488
Ingredient (HICL) Ciprofloxacin Hcl/Dexameth
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 CIPROFLOX-DEXAMETH OTIC SUSP
FDB brand name Ciprofloxacin-Dexamethasone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 052911
  • GCN: 20188
  • GPI-14 (Medi-Span): 87991002361820
  • HICL (First Databank): 025488
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 403908
Why two NDCs? The FDA registers this code as 53746-831-53 — 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 → 53746-0831-53. 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.

Clinical

Label name CIPROFLOX-DEXAMETH OTIC SUSP Ingredient Ciprofloxacin Hcl/Dexameth

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.

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 $7.124 $53.43 / 7.5 ml
Medicaid paysCMS SDUD · 12 mo $12.35 $92.61 / 7.5 ml
Medicare drug plans payPart D · Q2 2026 $13.23 $99.21 / 7.5 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $8.682 $6.945
▼ Down 17% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53746-0831-53 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 7.5 mL in 1 BOTTLE, PLASTIC 2024-03-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 00781-6186-67 Sandoz 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 00832-1430-75 Upsher-Smith 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 16714-0628-01 NorthStar 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 43598-0326-75 Dr. 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mLthis 53746-0831-53 Amneal 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 62756-0427-90 Sun 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 70244-0033-01 Sentiss 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 72485-0625-13 ARMAS 1 bottle $7.124 AB Availability likely —
Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 67296-1943-08 Redpharm 1 bottle — AB FDA listed —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 67296-2257-08 Redpharm 1 bottle — AB FDA listed —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-3804-07 NuCare 1 bottle — AB FDA listed —
Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 68071-3977-07 NuCare 1 bottle — AB FDA listed —
Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 85766-0245-75 Sportpharm 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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.

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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • 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 R33S7TK2EP
    Hydroxyethyl cellulose is a thickening agent made from processed plant cellulose. It's used in medicines to increase viscosity, improve texture, and help distribute active ingredients evenly throughout liquid or semi-solid 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 Y27PUL9H56
    Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
  • 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.

11 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.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals of New York LLC
Application holderAMNEAL EU LTD
FDA applicationANDA216501 (ANDA)
Labeler code53746
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio228 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 115 words ▾

1 INDICATIONS AND USAGE Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa .

( 1 )

⏱️ Dosage and Administration 206 words ▾

2 DOSAGE AND ADMINISTRATION Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection. ( 2.1 ) Shake well immediately before use. ( 2.1 ) Instill four drops into the affected ear twice daily, for seven days. ( 2.2 )

2.1Important Administration Instructions Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, and not for ophthalmic use, or for injection. Shake well immediately before use.

2.2Dosage For the Treatment of Acute Otitis Externa (age 6 months and older) The recommended dosage regimen is as follows: Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic suspension, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)] instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled.

This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS Ciprofloxacin and dexamethasone otic suspension, USP: Each mL contains ciprofloxacin hydrochloride USP, 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone USP, 0.1% (equivalent to 1 mg dexamethasone, USP). Otic Suspension: Each mL of ciprofloxacin and dexamethasone otic suspension, USP contains ciprofloxacin hydrochloride USP, 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone USP, 0.1% (equivalent to 1 mg dexamethasone, USP). ( 3 )

⛔ Contraindications 106 words ▾

4 CONTRAINDICATIONS Ciprofloxacin and dexamethasone otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. Ciprofloxacin and dexamethasone otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.

( 4 ) Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. ( 4 )

⚠️ Warnings and Cautions 208 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin and dexamethasone. ( 5.1 ) Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. ( 5.2 )

5.1Hypersensitivity Reactions Ciprofloxacin and dexamethasone 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. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnea, urticaria, and itching.

5.2Potential for Microbial Overgrowth with Prolonged Use Prolonged use of ciprofloxacin and dexamethasone otic suspension may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

5.3Continued or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition, such as cholesteatoma, foreign body, or a tumor.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2) ]. Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phases II and III clinical trials, a total of 537 patients were treated with ciprofloxacin and dexamethasone otic suspension with AOE. The reported adverse reactions are listed below: Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes.

Adverse Reactions Incidence (N = 537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin and dexamethasone otic suspension. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on ciprofloxacin and dexamethasone otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Because of the minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration of ciprofloxacin and dexamethasone otic suspension, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women [see Clinical Pharmacology (12.3) ] .

Animal reproduction studies have not been conducted with ciprofloxacin and dexamethasone otic suspension. Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data). These doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA).

With dexamethasone, malformations have been observed in animal studies after ocular and systemic administration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20% respectively. Data Animal Data Ciprofloxacin Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. The doses used in these studies are, at a minimum, approximately 200 times greater than the recommended otic human dose based on body surface area.

In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days (GD), 6 to 17) were not associated with adverse developmental outcomes, including embryo-fetal toxicity or malformations. A 30 mg/kg oral dose was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. Intravenous administration of doses up to 20 mg/kg to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed.

To mitigate maternal toxicity in these studies, groups of rabbits received ciprofloxacin for a different 5 day dosing period covering organogenesis (GD 6 to 18). Dexamethasone Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application. In a rat oral developmental toxicity study, no adverse effects were observed at 0.01 mg/kg/day (0.1 times the ROHD based on BSA), although embryotoxicity was observed at higher doses.

8.2Lactation Risk Summary It is not known whether ciprofloxacin and dexamethasone are present in human milk following topical otic administration. Published literature reports the presence of ciprofloxacin in human milk after oral administration to lactating women. However, because of the minimal systemic absorption of ciprofloxacin following topical otic administration of ciprofloxacin and dexamethasone otic suspension, breastfeeding is not expected to result in the exposure of the infant to ciprofloxacin [see Clinical Pharmacology (12.3) ] .

Systemically administered corticosteroids appear in human milk. Dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. However, it is not known whether topical otic administration of ciprofloxacin and dexamethasone otic suspension could result in systemic absorption that is sufficient to produce detectable quantities of dexamethasone in human milk.

There are no data on the effects of ciprofloxacin or dexamethasone on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinic… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on ciprofloxacin and dexamethasone otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Because of the minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration of ciprofloxacin and dexamethasone otic suspension, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women [see Clinical Pharmacology (12.3) ] .

Animal reproduction studies have not been conducted with ciprofloxacin and dexamethasone otic suspension. Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data). These doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA).

With dexamethasone, malformations have been observed in animal studies after ocular and systemic administration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20% respectively. Data Animal Data Ciprofloxacin Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. The doses used in these studies are, at a minimum, approximately 200 times greater than the recommended otic human dose based on body surface area.

In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days (GD), 6 to 17) were not associated with adverse developmental outcomes, including embryo-fetal toxicity or malformations. A 30 mg/kg oral dose was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. Intravenous administration of doses up to 20 mg/kg to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed.

To mitigate maternal toxicity in these studies, groups of rabbits received ciprofloxacin for a different 5 day dosing period covering organogenesis (GD 6 to 18). Dexamethasone Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application. In a rat oral developmental toxicity study, no adverse effects were observed at 0.01 mg/kg/day (0.1 times the ROHD based on BSA), although embryotoxicity was observed at higher doses.

🧒 Pediatric Use 61 words ▾

8.4Pediatric Use The safety and efficacy of ciprofloxacin and dexamethasone otic suspension have been established in pediatric patients 6 months and older (537 patients) in adequate and well-controlled clinical trials. No clinically relevant changes in hearing function were observed in 69 pediatric patients (age 4 to 12 years) treated with ciprofloxacin and dexamethasone otic suspension and tested for audiometric parameters.

🆘 Overdosage 23 words ▾

10 OVERDOSAGE Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ciprofloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4) ]. Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

12.3Pharmacokinetics Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg ciprofloxacin, 0.28 mg dexamethasone) topical otic dose of ciprofloxacin and dexamethasone otic suspension to pediatric patients, measurable plasma concentrations of ciprofloxacin and dexamethasone were observed at 6 hours following administration in 2 of 9 patients and 5 of 9 patients, respectively. Mean ± SD peak plasma concentrations of ciprofloxacin were 1.39 ± 0.880 ng/mL (n = 9). Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on average approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250 mg.

Peak plasma concentrations of ciprofloxacin were observed within 15 minutes to 2 hours post dose application. Mean ± SD peak plasma concentrations of dexamethasone were 1.14 ± 1.54 ng/mL (n = 9). Peak plasma concentrations ranged from 0.135 ng/mL to 5.10 ng/mL and were on average approximately 14% of peak concentrations reported in the literature following an oral 0.5 mg tablet dose.

Peak plasma concentrations of dexamethasone were observed within 15 minutes to 2 hours post dose application. Dexamethasone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection.

12.4Microbiology Mechanism of Action The bactericidal action of ciprofloxacin results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA. Resistance Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of anti-bacterial agents, such as beta-lactams or aminoglycosides.

Antimicrobial Activity Ciprofloxacin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections [see Indications and Usage (1) ]. Aerobic Bacteria Gram-positive Bacteria Staphylococcus aureus Gram-negative Bacteria Pseudomonas aeruginosa

🧬 Mechanism of Action 40 words ▾

12.1Mechanism of Action Ciprofloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4) ]. Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

📦 How Supplied / Storage and Handling 102 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP, is a sterile white to off white homogenous suspension supplied as 7.5 mL fill in a system consisting of a 10 mL LDPE natural bottle, 30 µL LDPE natural nozzle and a HDPE white opaque screw-on cap with tamper evident ring for tamper evident feature. It is available as follows: 7.5 mL in a 10 mL Container: NDC 53746-831-53 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Avoid freezing. Protect from light.

📋 Description 180 words ▾

11 DESCRIPTION Ciprofloxacin and Dexamethasone Otic Suspension, USP contains the quinolone antimicrobial, ciprofloxacin hydrochloride, USP, combined with the corticosteroid, dexamethasone USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin and dexamethasone otic suspension, USP contains ciprofloxacin hydrochloride, USP (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, USP, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are acetic acid, boric acid, edetate disodium (as dihydrate), hydroxyethyl cellulose, sodium acetate trihydrate, sodium chloride, tyloxapol and water for injection, USP.

Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The molecular formula is C 17 H 18 FN 3 O 3 ·HCl·H 2 O.

The molecular weight is 385.82 g/mol and the structural formula is: Figure 1: Structure of Ciprofloxacin Dexamethasone USP, (11β,16α)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The molecular formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol and the structural formula is: Figure 2: Structure of Dexamethasone structure 1 structure 2

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). For Otic Use Only Advise patients that ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only. This product must not be used in the eye [see Dosage and Administration (2.2) ] .

Administration Instructions Instruct patients to warm the bottle in their hand for one to two minutes prior to use and shake well immediately before using [see Dosage and Administration (2.1 , 2.2) ] . Allergic Reactions Advise patients to discontinue use immediately and contact their physician, if rash or allergic reaction occurs [see Warnings and Precautions (5.1) ] . Avoid Contamination of the Product Advise patients to avoid contaminating the tip with material from the ear, fingers, or other sources [see Instructions for Use ] .

Duration of Use Advise patients that it is very important to use the eardrops for as long as their doctor has instructed, even if the symptoms improve [see Patient Information ] . Protect from Light Advise patients to protect the product from light [see How Supplied/Storage and Handling (16) ] . Unused Product Advise patients to discard unused portion after therapy is completed [see Dosage and Administration (2.2) ] .

Manufactured by: Amneal Pharmaceuticals Private Limited Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2022-00

🧬 Pharmacokinetics 193 words ▾

12.3Pharmacokinetics Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg ciprofloxacin, 0.28 mg dexamethasone) topical otic dose of ciprofloxacin and dexamethasone otic suspension to pediatric patients, measurable plasma concentrations of ciprofloxacin and dexamethasone were observed at 6 hours following administration in 2 of 9 patients and 5 of 9 patients, respectively. Mean ± SD peak plasma concentrations of ciprofloxacin were 1.39 ± 0.880 ng/mL (n = 9). Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on average approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250 mg.

Peak plasma concentrations of ciprofloxacin were observed within 15 minutes to 2 hours post dose application. Mean ± SD peak plasma concentrations of dexamethasone were 1.14 ± 1.54 ng/mL (n = 9). Peak plasma concentrations ranged from 0.135 ng/mL to 5.10 ng/mL and were on average approximately 14% of peak concentrations reported in the literature following an oral 0.5 mg tablet dose.

Peak plasma concentrations of dexamethasone were observed within 15 minutes to 2 hours post dose application. Dexamethasone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection.

🔬 Clinical Studies 109 words ▾

14 CLINICAL STUDIES In 2 randomized multicenter, controlled clinical trials, ciprofloxacin and dexamethasone otic suspension dosed 2 times per day for 7 days demonstrated clinical cures in 87% and 94% of per protocol evaluable AOE patients, respectively, compared to 84% and 89%, respectively, for otic suspension containing neomycin 0.35%, polymyxin B 10,000 units/mL, and hydrocortisone 1.0% (neo/poly/HC). Among culture-positive patients clinical cures were 86% and 92% for ciprofloxacin and dexamethasone otic suspension compared to 84% and 89%, respectively, for neo/poly/HC.

Microbiological eradication rates for these patients in the same clinical trials were 86% and 92% for ciprofloxacin and dexamethasone otic suspension compared to 85% and 85%, respectively, for neo/poly/HC.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of ciprofloxacin and dexamethasone otic suspension have been performed to evaluate carcinogenic potential.

Long-term studies have not been performed to evaluate the carcinogenic potential of topical otic dexamethasone. Mutagenesis Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella /Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Dexamethasone has been tested for in vitro and in vivo genotoxic potential and shown to be positive in the following assays: chromosomal aberrations, sister-chromatid exchange in human lymphocytes, and micronuclei and sister-chromatid exchanges in mouse bone marrow.

However, the Ames/Salmonella assay, both with and without S9 mix, did not show any increase in His+ revertants. Impairment of Fertility Fertility studies performed in male and female rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 482 times the ROHD of ciprofloxacin based on BSA) revealed no evidence of impairment. Male rats received oral ciprofloxacin for 10 weeks prior to mating and females were dosed for 3 weeks prior to mating through GD 7.

The effect of dexamethasone on fertility has not been investigated following topical otic application. However, the lowest toxic dose of dexamethasone identified following topical dermal application was 1.802 mg/kg in a 26-week study in male rats and resulted in changes to the testes, epididymis, sperm duct, prostate, seminal vesicle, Cowper's gland, and accessory glands. The relevance of this study for short-term topical otic use is unknown.

13.2Animal Toxicology and/or Pharmacology Guinea pigs dosed in the middle ear with ciprofloxacin and dexamethasone otic suspension for one month exhibited no drug-related structural or functional changes of the cochlear hair cells and no lesions in the ossicles.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of ciprofloxacin and dexamethasone otic suspension have been performed to evaluate carcinogenic potential.

Long-term studies have not been performed to evaluate the carcinogenic potential of topical otic dexamethasone. Mutagenesis Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella /Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Dexamethasone has been tested for in vitro and in vivo genotoxic potential and shown to be positive in the following assays: chromosomal aberrations, sister-chromatid exchange in human lymphocytes, and micronuclei and sister-chromatid exchanges in mouse bone marrow.

However, the Ames/Salmonella assay, both with and without S9 mix, did not show any increase in His+ revertants. Impairment of Fertility Fertility studies performed in male and female rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 482 times the ROHD of ciprofloxacin based on BSA) revealed no evidence of impairment. Male rats received oral ciprofloxacin for 10 weeks prior to mating and females were dosed for 3 weeks prior to mating through GD 7.

The effect of dexamethasone on fertility has not been investigated following topical otic application. However, the lowest toxic dose of dexamethasone identified following topical dermal application was 1.802 mg/kg in a 26-week study in male rats and resulted in changes to the testes, epididymis, sperm duct, prostate, seminal vesicle, Cowper's gland, and accessory glands. The relevance of this study for short-term topical otic use is unknown.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Ciprofloxacin (sip״ roe flox׳ a sin) and Dexamethasone (dex״ a meth׳ a sone) Otic Suspension, USP What is ciprofloxacin and dexamethasone otic suspension? Ciprofloxacin and dexamethasone otic suspension is a prescription medicine used in the ear only (otic use) that contains 2 medicines, a quinolone antibiotic medicine called ciprofloxacin and a corticosteroid medicine called dexamethasone. Ciprofloxacin and dexamethasone otic suspension is used in adults and children 6 months of age or older to treat certain types of infections caused by certain germs called bacteria.

These bacterial infections include: outer ear canal infection (known as acute otitis externa or AOE) It is not known if ciprofloxacin and dexamethasone otic suspension is safe and effective in children under 6 months of age. Who should not use ciprofloxacin and dexamethasone otic suspension? Do not use ciprofloxacin and dexamethasone otic suspension if you: are allergic to ciprofloxacin, quinolones, or any of the ingredients in ciprofloxacin and dexamethasone otic suspension.

See the end of this Patient Information leaflet for a complete list of ingredients in ciprofloxacin and dexamethasone otic suspension. have an outer ear canal infection caused by certain viruses, including the herpes simplex virus. have an ear infection caused by a fungus. What should I tell my doctor before using ciprofloxacin and dexamethasone otic suspension? Before using ciprofloxacin and dexamethasone otic suspension, tell your doctor about all of your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if ciprofloxacin and dexamethasone otic suspension will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ciprofloxacin and dexamethasone passes into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with ciprofloxacin and dexamethasone otic suspension.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ciprofloxacin and dexamethasone otic suspension? Read the detailed Instructions for Use that come with ciprofloxacin and dexamethasone otic suspension.

Use ciprofloxacin and dexamethasone otic suspension exactly as your doctor tells you to. Ciprofloxacin and dexamethasone otic suspension is for use in the ear only (otic use) . Do not use ciprofloxacin and dexamethasone otic suspension in the eye or inject ciprofloxacin and dexamethasone otic suspension .

Apply 4 drops of ciprofloxacin and dexamethasone otic suspension into the affected ear 2 times a day for 7 days. Do not stop using ciprofloxacin and dexamethasone otic suspension unless your doctor tells you to, even if your symptoms improve. If your symptoms do not improve after 7 days of treatment with ciprofloxacin and dexamethasone otic suspension, call your doctor.

Call your doctor right away if: you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with ciprofloxacin and dexamethasone otic suspension you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with ciprofloxacin and dexamethasone otic suspension What are the possible side effects of ciprofloxacin and dexamethasone otic suspension? C iprofloxacin and dexamethasone otic suspension may cause serious side effects, including: allergic reactions .

Stop using ciprofloxacin and dexamethasone otic suspension and call your doctor or go to the nearest emergency room if you have any of the following signs or symptoms of an allergic reaction: hives (urticaria) swelling of your face, lips, mouth, or tongue rash itching trouble breathing dizziness, fast heartbeat, or pounding in your chest The most common side effects of ciprofloxacin and dexamethasone otic suspension include: ear discomfort ear pain ear itching (pruritus) These are not all the possible si… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Ciprofloxacin (sip״ roe flox׳ a sin) and Dexamethasone (dex״ a meth׳ a sone) Otic Suspension, USP This “Instructions for Use” contains information on how to use ciprofloxacin and dexamethasone otic suspension. Important Information You Need to Know Before Using Ciprofloxacin and Dexamethasone Otic Suspension. Read this Instructions for Use that comes with ciprofloxacin and dexamethasone otic suspension before you start using it and each time you get a refill.

There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Use ciprofloxacin and dexamethasone otic suspension exactly as your doctor tells you to use it.

Ciprofloxacin and dexamethasone otic suspension is for use in the ear only (otic use) . Do not inject ciprofloxacin and dexamethasone otic suspension or use ciprofloxacin and dexamethasone otic suspension in the eye. Shake ciprofloxacin and dexamethasone otic suspension well before each use .

Do not touch your ear, fingers, or other surfaces with the tip of the ciprofloxacin and dexamethasone otic suspension bottle. You may get bacteria on the tip of the bottle that can cause you to get another infection. How should I use ciprofloxacin and dexamethasone otic suspension?

Step 1. Wash your hands with soap and water (see Figure A ). Figure A Step 2.

Warm the bottle of ciprofloxacin and dexamethasone otic suspension by rolling the bottle between your hands for 1 to 2 minutes (see Figure B ). Shake the bottle of ciprofloxacin and dexamethasone otic suspension well. Figure B Step 3.

Remove the ciprofloxacin and dexamethasone otic suspension cap. Put the cap in a clean and dry area. Do not let the tip of the bottle touch your ear, fingers or other surfaces.

Step 4. Lie down on your side so that the affected ear faces upward (see Figure C ). Figure C Step 5.

Hold the bottle of ciprofloxacin and dexamethasone otic suspension between your thumb and index finger (see Figure D ). Place the tip of the bottle close to your ear. Be careful not to touch your fingers or ear with the tip of the bottle .

Figure D Step 6. Gently squeeze the bottle and let 4 drops of ciprofloxacin and dexamethasone otic suspension fall into the affected ear. If a drop misses your ear, follow the instructions in Step 5 again.

Step 7. Stay on your side with the affected ear facing upward (see Figure C ). It is important that you follow the instructions below for your specific ear infection , to allow ciprofloxacin and dexamethasone otic suspension to enter the affected part of your ear.

Step 8. If you use ciprofloxacin and dexamethasone otic suspension to treat an outer ear canal infection: Gently pull the outer ear lobe upward and backward (see Figure F ). This will allow the drops of ciprofloxacin and dexamethasone otic suspension to enter your ear canal.

Remain on your side with the affected ear facing upward (see Figure C ) for 1 minute . Figure F Step 9. If your doctor has told you to use ciprofloxacin and dexamethasone otic suspension in both ears, repeat steps 5-8 for your other ear.

Step 10. Put the cap back on the bottle and close it tightly. Step 11.

After you have used all of your ciprofloxacin and dexamethasone otic suspension doses, there may be some ciprofloxacin and dexamethasone otic suspension left in the bottle. Throw the bottle away. How should I store ciprofloxacin and dexamethasone otic suspension?

Store ciprofloxacin and dexamethasone otic suspension at room temperature at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Do not freeze ciprofloxacin and dexamethasone otic suspension. Keep ciprofloxacin and dexamethasone otic suspension out of light.

Keep ciprofloxacin and dexamethasone otic suspension and all medicines out of the reach of children. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for more information about ciprofloxacin and dexamethasone o… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 41 words ▾

PRINCIPAL DISPLAY PANEL NDC 53746-831-53 Ciprofloxacin and Dexamethasone Otic Suspension, USP 0.3%/0.1% (7.5 mL) Rx only Container Label Amneal Pharmaceuticals LLC NDC 53746-831-53 Ciprofloxacin and Dexamethasone Otic Suspension, USP 0.3%/0.1% (7.5 mL) Rx only Carton Label Amneal Pharmaceuticals LLC 1 2

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

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 this package alone, 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 – Q1 2026 · 5 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
22.8K
Units reimbursed last 4 qtrs
172.1K
Gross reimbursed last 4 qtrs
$2.12M
Avg / prescription
$93.08
Avg / unit
$12.3482
Latest quarter Q1 2026
779Rx
Medicaid pays / mL
$12.3482
gross reimbursed
vs
NADAC / mL
$7.1238
acquisition cost
=
Spread
+$5.2244
+73% 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 ⓘ
47% FFS 53% MCO
Fee-for-service · 10,791 Rx Managed care · 12,034 Rx
State Medicaid map
Alaska: 128 units · 17.5 per 100k residents AK Maine: 255 units · 18.3 per 100k residents ME Washington: 4,350 units · 55.7 per 100k residents WA Idaho: 788 units · 40.1 per 100k residents ID Montana: 210 units · 18.6 per 100k residents MT North Dakota: no data reported ND Minnesota: 2,340 units · 40.8 per 100k residents MN Wisconsin: 570 units · 9.6 per 100k residents WI Michigan: 7,253 units · 72.3 per 100k residents MI New York: 17,800 units · 91.0 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,553 units · 111 per 100k residents NH Oregon: 690 units · 16.3 per 100k residents OR Nevada: no data reported NV Wyoming: 285 units · 48.8 per 100k residents WY South Dakota: 1,283 units · 140 per 100k residents SD Iowa: 278 units · 8.7 per 100k residents IA Illinois: 2,835 units · 22.6 per 100k residents IL Indiana: 368 units · 5.4 per 100k residents IN Ohio: 3,180 units · 27.0 per 100k residents OH Pennsylvania: 1,793 units · 13.8 per 100k residents PA New Jersey: 8,093 units · 87.1 per 100k residents NJ Massachusetts: 105 units · 1.5 per 100k residents MA California: 30,968 units · 79.5 per 100k residents CA Utah: 255 units · 7.5 per 100k residents UT Colorado: 1,343 units · 22.8 per 100k residents CO Nebraska: 1,268 units · 64.1 per 100k residents NE Missouri: 158 units · 2.6 per 100k residents MO Kentucky: 5,146 units · 114 per 100k residents KY West Virginia: 3,645 units · 206 per 100k residents WV Virginia: 2,505 units · 28.7 per 100k residents VA Maryland: 1,373 units · 22.2 per 100k residents MD Connecticut: 1,575 units · 43.5 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,755 units · 23.6 per 100k residents AZ New Mexico: 113 units · 5.3 per 100k residents NM Kansas: 398 units · 13.5 per 100k residents KS Arkansas: 3,158 units · 103 per 100k residents AR Tennessee: 6,780 units · 95.1 per 100k residents TN North Carolina: 7,170 units · 66.2 per 100k residents NC South Carolina: 3,075 units · 57.2 per 100k residents SC Delaware: no data reported DE Oklahoma: 135 units · 3.3 per 100k residents OK Louisiana: 7,845 units · 172 per 100k residents LA Mississippi: no data reported MS Alabama: 8,903 units · 174 per 100k residents AL Georgia: 6,195 units · 56.2 per 100k residents GA D.C.: no data reported DC Hawaii: 120 units · 8.4 per 100k residents HI Texas: 5,153 units · 16.9 per 100k residents TX Florida: 18,878 units · 83.5 per 100k residents FL
Units reimbursed · per 100k residents
1.5206
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 West Virginia 206 /100k
2 Alabama 174 /100k
3 Louisiana 172 /100k
4 South Dakota 140 /100k
5 Kentucky 114 /100k
6 New Hampshire 111 /100k
7 Arkansas 103 /100k
8 Tennessee 95.1 /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.
← 53746-0778-10 · Amneal 53746-0837-05 · Amneal →
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.