Home › NDC Lookup › Ingredients › Ciprofloxacin Hydrochloride And Dexameth... › 00832-1430-75
👂image loading
(from DailyMed)

Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension, 1 bottle — NDC 0832-1430-75 (Billing 00832-1430-75)

by Upsher-Smith Laboratories, LLC · 1 BOTTLE in 1 CARTON / 7.5 mL in 1 BOTTLE

This is a package of 1 bottle of Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension from Upsher-Smith Laboratories, LLC, marketed since Jan 2026 and currently FDA-listed; retail pharmacies pay about $7.12 per mL (NADAC). It is this product's only package size.

NDC 00832-1430-75
🏷️ FDA NDC (as labeled) 0832-1430-75 billing pads the labeler 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0832-1430-75
Product NDC 0832-1430
11-digit billing NDC 00832143075
NCPDP billing unit ML — per mL (volume)
RxCUI 403908
UNII 4BA73M5E37, 7S5I7G3JQL
Application # ANDA216487
SPL Set ID 9c5994d1-01d1-493c-a6ae-94754cd59389
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 2026-01-06
Route AURICULAR (OTIC)
Dosage form SUSPENSION
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 0832-1430-75 — 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 → 00832-1430-75. 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $13.23 $99.21 / 7.5 ml
NADAC price history (per mL) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Sep 2026 $7.397 $6.945
▼ Down 4% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00832-1430-75 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 7.5 mL in 1 BOTTLE 2026-02-13 — 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/mLthis 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/mL 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 —
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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerUpsher-Smith Laboratories, LLC
Application holderUPSHER SMITH LABORATORIES LLC
FDA applicationANDA216487 (ANDA)
Labeler code00832
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio229 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 📦 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 180 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 Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa. ( 1 ) 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 Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa.

( 1 ) 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 ~2 min read ▾

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 )

2.1Important 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 Media in Pediatric Patients (age 6 months and older) With Tympanostomy Tubes The recommended dosage regimen through tympanostomy tubes is as follows: • Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic suspension, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of 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. • The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. • This position should be maintained for 60 seconds.

Repeat, if necessary, for the opposite ear. • Discard unused portion after therapy is completed. 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 64 words ▾

3 DOSAGE FORMS AND STRENGTHS Otic Suspension: Each mL of ciprofloxacin and dexamethasone, otic suspension, contains ciprofloxacin hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1% (equivalent to 1 mg dexamethasone). Otic Suspension: Each mL of ciprofloxacin and dexamethasone, otic suspension contains ciprofloxacin hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1% (equivalent to 1 mg dexamethasone). ( 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 210 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, otic suspension. ( 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 ~2 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 reaction was ear pruritus (1.5%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 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 937 patients were treated with ciprofloxacin and dexamethasone, otic suspension. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE.

The reported adverse reactions are listed below: Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes. Adverse Reactions Incidence (N = 400) Ear discomfort 3.0% Ear pain 2.3% Ear precipitate (residue) 0.5% Irritability 0.5% Taste Perversion 0.5% The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

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).

6.2Post-marketing 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 embryofetal 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 c… [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 embryofetal 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 (937 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 after tymoanostomy tube insertion, 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 (such as otorrhea in pediatric patients with AOMT).

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 Streptococcus pneumoniae Gram-negative Bacteria Haemophilus influenzae Moraxella catarrhalis Pseudomonas aeruginosa

🧬 Mechanism of Action 41 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 76 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ciprofloxacin 0.3% and dexamethasone 0.1%, otic suspension, USP is a white to off-white suspension supplied in a natural LDPE bottle, with a natural LDPE dropper and capped with a white HDPE cap. 7.5 mL in a 10 mL bottle NDC 0832-1430-75 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing. Protect from light.

📦 Storage and Handling 28 words ▾

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing. Protect from light.

📋 Description 184 words ▾

11 DESCRIPTION Ciprofloxacin 0.3% and dexamethasone 0.1% sterile 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, USP, otic suspension contains ciprofloxacin hydrochloride, USP (equivalent to 3 mg ciprofloxacin base) and 1 mg dexamethasone, USP. The inactive ingredients are acetic acid, boric acid, benzalkonium chloride (0.01%, as a preservative), edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol.

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 empirical 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, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical 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 FDA approved dissolution test specifications differ from USP.

Figure 1 Figure 2

💬 Information for Patients 209 words ▾

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) ] .

🧬 Pharmacokinetics 205 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 after tymoanostomy tube insertion, 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 (such as otorrhea in pediatric patients with AOMT).

🔬 Clinical Studies 205 words ▾

14 CLINICAL STUDIES In a randomized, multicenter, controlled clinical trial, ciprofloxacin and dexamethasone otic suspension dosed 2 times per day for 7 days demonstrated clinical cures in the per protocol analysis in 86% of AOMT patients compared to 79% for ofloxacin solution, 0.3%, dosed 2 times per day for 10 days. Among culture positive patients, clinical cures were 90% for ciprofloxacin and dexamethasone otic suspension compared to 79% for ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same clinical trial were 91% for ciprofloxacin and dexamethasone otic suspension compared to 82% for ofloxacin solution, 0.3%.

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 ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2025 PATIENT INFORMATION Ciprofloxacin and Dexamethasone (sip" ro∙flok' sah-sin and dex" sah-meth' ah∙sōn), otic suspension 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: • middle ear infection (known as acute otitis media or AOM) in people who have a tube in their eardrum known as a tympanostomy to prevent having too much fluid in the middle ear 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, otic suspension 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?

Ciprofloxacin 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 react… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 12/2025 INSTRUCTIONS FOR USE Ciprofloxacin and Dexamethasone (sip" ro∙flok' sah-sin and dex" sah-meth' ah∙sōn), otic suspension 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 byrolling 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 a middle ear infection, and you have a tube in your eardrum known as tympanostomy: • Gently press the part of the ear known as the tragus ( see Figure E) 5 times using a pumping motion (see Figure E ).

This will allow the drops of ciprofloxacin and dexamethasone otic suspension to enter your middle ear. • Remain on your side with the affected ear facing upward (see Figure C ) for 1 minute. Figure E If you use ciprofloxacin and dexamethasone otic suspension to treat anouter 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 through 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 stor… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 34 words ▾

PRINCIPAL DISPLAY PANEL - 7.5 mL Bottle Carton NDC 0832-1430-75 Ciprofloxacin and Dexamethasone, otic suspension (ciprofloxacin 0.3% and dexamethasone 0.1%) STERILE OTIC SUSPENSION FOR USE IN EARS ONLY 7.5 mL Rx only UPSHER-SMITH Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00832-1425-05 · Upsher-Smith 00832-1435-05 · Upsher-Smith →
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.