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Moxifloxacin ophthalmic solution 5 mg/mL Solution/ Drops — NDC 62332-505-03 (Billing 62332-0505-03)

by Alembic Pharmaceuticals Inc. · 1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE

This is a package of Moxifloxacin ophthalmic solution 5 mg/mL Solution/ Drops from Alembic Pharmaceuticals Inc., marketed since Feb 2019 and currently FDA-listed; retail pharmacies pay about $1.60 per mL (NADAC). It is this product's only package size.

NDC 62332-0505-03
🏷️ FDA NDC (as labeled) 62332-505-03 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 →

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

NDC database record

One package, one record: these facts belong to NDC 62332-505-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62332 labeler · 505 product · 03 package
Package marketed since
Feb 13, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6233250503 6
Medicaid fills, this package
29,946 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62332-505-03
Product NDC 62332-505
11-digit billing NDC 62332050503
NCPDP billing unit ML — per mL (volume)
RxCUI 403818
UNII C53598599T
Application # ANDA209469
SPL Set ID 0f2cdbf6-bc74-4b22-b795-23ace89894b3
Established class (EPC) Fluoroquinolone Antibacterial
Chemical class Fluoroquinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-13
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance MOXIFLOXACIN HYDROCHLORIDE
TE code (Orange Book) AT1 · RLD · RS

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

GPI-14 86101038102020
GPI class Moxifloxacin HCl
GCN Seq No 052050
GCN 19542
HICL code 020690
Ingredient (HICL) Moxifloxacin Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name MOXIFLOXACIN 0.5% EYE DROPS
FDB brand name Moxifloxacin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 052050
  • GCN: 19542
  • GPI-14 (Medi-Span): 86101038102020
  • HICL (First Databank): 020690
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 403818
Why two NDCs? The FDA registers this code as 62332-505-03 — 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 → 62332-0505-03. 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
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 MOXIFLOXACIN 0.5% EYE DROPS Ingredient Moxifloxacin Hcl
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for certain bacterial infections. As tablets or an IV, it treats pneumonia, skin infections, abdominal infections, sinus infections, bronchitis flare-ups and pl...
  • Take them once a day, with or without food. Keep them at least 4 hours before or 8 hours after antacids, iron, or multivitamins, because those can block absorption. Finish the cour...
  • How should I take my moxifloxacin tablets?
  • Nausea, diarrhea, headache and dizziness are the most common. Those are usually manageable. Call your doctor if you have severe or watery diarrhea, or any symptoms that worry you.
📖 Read our full Moxifloxacin guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.596 $4.79 / 3 ml
Medicaid paysCMS SDUD · 12 mo $4.94 $14.82 / 3 ml
Medicare drug plans payPart D · Q2 2026 $3.70 $11.11 / 3 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $5.102 $1.539
▼ Down 64% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62332-0505-03 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE 2019-02-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Moxifloxacin Ophthalmic Solution 5 mg/mL 00781-7135-93 Sandoz 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin Hydrochloride 5 mg/mL 00832-1410-03 Upsher-Smith 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin 5 mg/mL 16714-0643-01 NorthStar 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin 5 mg/mL 60505-0582-04 Apotex 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin ophthalmic solution 5 mg/mLthis 62332-0505-03 Alembic 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin 5 mg/mL 65862-0840-03 Aurobindo 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin 5 mg/mL 68180-0422-01 Lupin 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin Hydrochloride 5 mg/mL 70069-0081-01 Somerset 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin ophthalmic solution 5 mg/mL 70756-0638-25 Lifestar 1 bottle $1.596 AT1 Availability likely —
Moxifloxacin Ophthalmic Solution 5 mg/mL 72266-0158-01 Fosun 1 bottle $1.596 AT1 Availability likely —
Vigamox 5 mg/mL 82667-0700-03 Harrow 1 bottle $31.808 AT1 Availability likely +1893%
Moxifloxacin ophthalmic solution 5 mg/mL 46708-0505-03 Alembic 1 bottle — AT1 FDA listed —
Moxifloxacin ophthalmic solution 5 mg/mL 50090-4781-00 A-S 1 bottle — AT1 FDA listed —
Moxifloxacin Ophthalmic 5 mg/mL 50090-6248-00 A-S 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 50090-6357-00 A-S 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 51407-0321-03 Golden 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 67296-2129-03 Redpharm 1 bottle — AT1 FDA listed —
Moxifloxacin ophthalmic solution 5 mg/mL 67296-2222-03 Redpharm 1 bottle — AT1 FDA listed —
Moxifloxacin Hydrochloride 5 mg/mL 67296-2232-03 Redpharm 1 bottle — AT1 FDA listed —
Moxifloxacin Ophthalmic Solution 5 mg/mL 68083-0210-01 Gland 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 68180-0421-01 Lupin 3 ml — — FDA listed —
Moxifloxacin 5 mg/mL 72162-2107-02 Bryant 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 72189-0321-05 Direct 3 ml — AT1 FDA listed —
Moxifloxacin 5 mg/mL 72189-0334-05 Direct 3 ml — — FDA listed —
Moxifloxacin Hydrochloride 5 mg/mL 76420-0331-03 Asclemed 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 80425-0239-01 Advanced 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 80425-0379-01 Advanced 1 bottle — AT1 FDA listed —
Moxifloxacin 5 mg/mL 82804-0055-03 Proficient 1 bottle — AT1 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

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 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.

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

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA209469 (ANDA)
Labeler code62332
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio492 products on file

More NDCs from Alembic Pharmaceuticals Inc. labeler code 62332

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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 125 words ▾

1 INDICATIONS AND USAGE Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.

MOXIFLOXACIN ophthalmic solution is a topical fluoroquinolone anti- infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis , Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii* , Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.

⏱️ Dosage and Administration 40 words ▾

2 DOSAGE AND ADMINISTRATION Instill one drop in the affected eye 3 times a day for 7 days. Moxifloxacin ophthalmic solution is for topical ophthalmic use. Instill one drop in the affected eye 3 times a day for 7 days.

💊 Dosage Forms and Strengths 15 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing moxifloxacin 0.5%. Ophthalmic solution containing moxifloxacin 0.5%.

⛔ Contraindications 54 words ▾

4 CONTRAINDICATIONS Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. MOXIFLOXACIN ophthalmic solution is contraindicated in patients with a history of hypersensitivity to MOXIFLOXACIN, to other quinolones, or to any of the components in this medication.

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Hypersensitivity and anaphylaxis have been reported with systemic use of MOXIFLOXACIN. ( 5.1) • Prolonged use : May result in overgrowth of non- susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

( 5.2) • Avoid Contact Lens Wear : Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.3 )

5.1Hypersensitivity Reactions In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug.

Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

5.2Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

5.3Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

🤒 Adverse Reactions 157 words ▾

6 ADVERSE REACTIONS 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. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.

Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1 to 6% of patients.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 46 words ▾

7 DRUG INTERACTIONS Drug-drug interaction studies have not been conducted with moxifloxacin ophthalmic solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. Oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses. Oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses [see Data].

Data Animal Data Embryo-fetal studies were conducted in pregnant rats administered with 20, 100 or 500 mg/kg/day moxifloxacin by oral gavage on Gestation Days 6 to 17, to target the period of organogenesis. Decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day (277 times the human AUC at the recommended human ophthalmic dose). The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (30 times the human AUC at the recommended human ophthalmic dose).

Embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5 or 20 mg/kg/day moxifloxacin by intravenous administration on Gestation Days 6 to 20, to target the period of organogenesis. Abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human AUC at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death. The NOAEL for developmental toxicity was 6.5 mg/kg/day (246 times the human AUC at the recommended human ophthalmic dose).

Pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30 or 100 mg/kg/day by intragastric intubation between Gestation Days 20 and 50, targeting the period of organogenesis. At the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting and diarrhea were observed. Smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human AUC at the recommended human ophthalmic dose).

The NOAEL for fetal toxicity was 10 mg/kg/day (174 times the human AUC at the recommended human ophthalmic dose). In a pre and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100 and 500 mg/kg/day from Gestation Day 6 until the end of lactation. Maternal death occurred during gestation at 500 mg/kg/day.

Slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human AUC at the recommended human ophthalmic dose). The NOAEL for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human AUC at the recommended human ophthalmic dose).

8.2Lactation Risk Summary There is no data regarding the presence of moxifloxacin ophthalmic solution in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of moxifloxacin ophthalmic solution to an infant during lactation. A study in lactating rats has shown transfer of moxifloxacin into milk following oral administration. Systemic levels of moxifloxacin following topical ocular administration are low [see Clinical Pharmacology (12.3)], and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin ophthalmic solution and any potential adverse effects on the breastfed child from moxifloxacin ophthalmic solution.

8.4Pediatric Use The safety and effectiveness of moxifloxacin ophthalmic solution 0.5% have been established in all ages. Use of moxifloxacin ophthalmic solution is supported by evidence from adequate and w… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. Oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses. Oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses [see Data].

Data Animal Data Embryo-fetal studies were conducted in pregnant rats administered with 20, 100 or 500 mg/kg/day moxifloxacin by oral gavage on Gestation Days 6 to 17, to target the period of organogenesis. Decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day (277 times the human AUC at the recommended human ophthalmic dose). The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (30 times the human AUC at the recommended human ophthalmic dose).

Embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5 or 20 mg/kg/day moxifloxacin by intravenous administration on Gestation Days 6 to 20, to target the period of organogenesis. Abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human AUC at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death. The NOAEL for developmental toxicity was 6.5 mg/kg/day (246 times the human AUC at the recommended human ophthalmic dose).

Pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30 or 100 mg/kg/day by intragastric intubation between Gestation Days 20 and 50, targeting the period of organogenesis. At the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting and diarrhea were observed. Smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human AUC at the recommended human ophthalmic dose).

The NOAEL for fetal toxicity was 10 mg/kg/day (174 times the human AUC at the recommended human ophthalmic dose). In a pre and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100 and 500 mg/kg/day from Gestation Day 6 until the end of lactation. Maternal death occurred during gestation at 500 mg/kg/day.

Slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human AUC at the recommended human ophthalmic dose). The NOAEL for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human AUC at the recommended human ophthalmic dose).

🧒 Pediatric Use 83 words ▾

8.4Pediatric Use The safety and effectiveness of moxifloxacin ophthalmic solution 0.5% have been established in all ages. Use of moxifloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of moxifloxacin ophthalmic solution in adults, children, and neonates [ see Clinical Studies (14) ]. There is no evidence that the ophthalmic administration of moxifloxacin ophthalmic solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs (See

12.4Microbiology).

12.3Pharmacokinetics Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin ophthalmic solution 3 times a day. The mean steady-state C max (2.7 ng/mL) and AUC 0-∞ (41.9 ng•hr/mL) values were 1600 and 1100 times lower than the mean C max and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 3 hours.

12.4Microbiology The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics.

Cross resistance has been observed between systemic moxifloxacin and some other quinolones. In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10 -9 to less than 1 x 10 -11 for gram-positive bacteria.

Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the Indications and Usage section: Aerobic Gram-positive microorganisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Aerobic Gram-negative microorganisms: Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Other microorganisms: Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.

The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown . The safety and effectiveness of moxifloxacin ophthalmic solution in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials. The following organisms are considered susceptible when evaluated using systemic breakpoints.

However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 microgram/mL or less (systemic susceptible breakpoint) against most (greater than or equal to 90%) strains of the following ocular pathogens.

Aerobic Gram-positive microorganisms Listeria monocytogenes Staphylococcus saprophyticus Streptococcus agalactiae Streptococcus mitis Streptococcus pyogenes Streptococcus Group C, G and F Aerobic Gram-negative microorganisms Acinetobacter baumannii Acinetobacter calcoaceticus Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Moraxella catarrhalis Morganella morganii Neisseria gonorrhoeae Proteus mirabilis Proteus vulgaris Pseudomonas stutzeri Anaerobic microorganisms Clostridium perfringens Fusobacterium species Prevotella species Propionibacterium acnes Other microorganisms Chlamydia pneumoniae Legionella pneumophila Mycobacte… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 18 words ▾

12.1Mechanism of Action Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs (See

12.4Microbiology).

📦 How Supplied / Storage and Handling 62 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Moxifloxacin ophthalmic solution USP is supplied as a sterile ophthalmic solution in dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan high density polyethylene closure. Tamper evidence is provided with container closure. 3 mL in a 5 mL bottle - NDC 62332-505-03 Storage: Store at 2˚C to 25˚C (36˚F to 77˚F).

📋 Description 147 words ▾

11 DESCRIPTION Moxifloxacin ophthalmic solution USP 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1- Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)octahydro-6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride.

The molecular formula for moxifloxacin hydrochloride is C 21 H 24 F 3 N 4 O•HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Moxifloxacin ophthalmic solution USP contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base.

Moxifloxacin ophthalmic solution USP contains Active : Moxifloxacin 0.5% (5 mg/mL); Inactives : Boric acid, water for injection, and sodium chloride. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg. moxifloxacin-structure

💬 Information for Patients 137 words ▾

17 PATIENT COUNSELING INFORMATION Avoid Contamination of the Product Advise patients not to touch the dropper tip to any surface to avoid contaminating the contents. Avoid Contact Lens Wear Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis [see Warnings and Precautions (5.3)] . Hypersensitivity Reactions Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose.

Instruct patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction [see Warnings and Precautions (5.1) ]. Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Made in India Manufactured by: Gland Pharma Limited D.P.

Pally, Dundigal Post, Hyderabad-500 043, India (IND) (or) Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391 450, Gujarat, India. Revised: February, 2023

🧬 Pharmacokinetics 74 words ▾

12.3Pharmacokinetics Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin ophthalmic solution 3 times a day. The mean steady-state C max (2.7 ng/mL) and AUC 0-∞ (41.9 ng•hr/mL) values were 1600 and 1100 times lower than the mean C max and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 3 hours.

🔬 Clinical Studies 129 words ▾

14 CLINICAL STUDIES In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, moxifloxacin ophthalmic solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%. In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis between birth and 31 days of age, patients were dosed with moxifloxacin ophthalmic solution or another anti-infective agent.

Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 92% at Day 9. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (3224 times the highest recommended total daily human ophthalmic dose for a 60 kg person, based on body surface area). Mutagenesis Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay.

As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when V79 cells were used.

Moxifloxacin was clastogenic in the V79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice. Impairment of Fertility Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 3224 times the highest recommended total daily human ophthalmic dose, based on body surface area.

At 500 mg/kg/day orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (3224 times the highest recommended total daily human ophthalmic dose for a 60 kg person, based on body surface area). Mutagenesis Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay.

As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when V79 cells were used.

Moxifloxacin was clastogenic in the V79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice. Impairment of Fertility Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 3224 times the highest recommended total daily human ophthalmic dose, based on body surface area.

At 500 mg/kg/day orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

📄 Package Label / Principal Display Panel 40 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - Bottle Label - Gland PRINCIPAL DISPLAY PANEL - Carton Label - Gland PRINCIPAL DISPLAY PANEL - Bottle Label - Alembic PRINCIPAL DISPLAY PANEL - Carton Label - Alembic moxifloxacin-bottle-gland moxifloxacin-carton-gland moxifloxacin-bottle-alembic moxifloxacin-carton-alembic

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
29.9K
Units reimbursed last 4 qtrs
92K
Gross reimbursed last 4 qtrs
$454.3K
Avg / prescription
$15.17
Avg / unit
$4.9392
Latest quarter Q1 2026
9KRx
Medicaid pays / mL
$4.9392
gross reimbursed
vs
NADAC / mL
$1.5963
acquisition cost
=
Spread
+$3.3429
+209% 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 ⓘ
44% FFS 56% MCO
Fee-for-service · 13,136 Rx Managed care · 16,810 Rx
State Medicaid map
Alaska: no data reported AK Maine: 591 units · 42.4 per 100k residents ME Washington: 1,323 units · 16.9 per 100k residents WA Idaho: 708 units · 36.0 per 100k residents ID Montana: 174 units · 15.4 per 100k residents MT North Dakota: no data reported ND Minnesota: 2,031 units · 35.4 per 100k residents MN Wisconsin: 4,356 units · 73.7 per 100k residents WI Michigan: 2,043 units · 20.4 per 100k residents MI New York: 3,303 units · 16.9 per 100k residents NY Vermont: 228 units · 35.2 per 100k residents VT New Hampshire: 150 units · 10.7 per 100k residents NH Oregon: 249 units · 5.9 per 100k residents OR Nevada: 708 units · 22.2 per 100k residents NV Wyoming: 111 units · 19.0 per 100k residents WY South Dakota: 456 units · 49.6 per 100k residents SD Iowa: 1,389 units · 43.3 per 100k residents IA Illinois: 180 units · 1.4 per 100k residents IL Indiana: 234 units · 3.4 per 100k residents IN Ohio: 3,219 units · 27.3 per 100k residents OH Pennsylvania: 1,140 units · 8.8 per 100k residents PA New Jersey: 2,751 units · 29.6 per 100k residents NJ Massachusetts: 1,100 units · 15.7 per 100k residents MA California: 16,305 units · 41.8 per 100k residents CA Utah: 225 units · 6.6 per 100k residents UT Colorado: 1,821 units · 31.0 per 100k residents CO Nebraska: no data reported NE Missouri: 2,829 units · 45.7 per 100k residents MO Kentucky: 1,656 units · 36.6 per 100k residents KY West Virginia: 282 units · 15.9 per 100k residents WV Virginia: 876 units · 10.1 per 100k residents VA Maryland: 1,953 units · 31.6 per 100k residents MD Connecticut: 1,944 units · 53.7 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,101 units · 14.8 per 100k residents AZ New Mexico: 327 units · 15.5 per 100k residents NM Kansas: 663 units · 22.6 per 100k residents KS Arkansas: 648 units · 21.1 per 100k residents AR Tennessee: 3,366 units · 47.2 per 100k residents TN North Carolina: 11,631 units · 107 per 100k residents NC South Carolina: 618 units · 11.5 per 100k residents SC Delaware: 1,626 units · 158 per 100k residents DE Oklahoma: 1,083 units · 26.7 per 100k residents OK Louisiana: 5,634 units · 123 per 100k residents LA Mississippi: 1,440 units · 49.0 per 100k residents MS Alabama: 1,620 units · 31.7 per 100k residents AL Georgia: 195 units · 1.8 per 100k residents GA D.C.: no data reported DC Hawaii: 125 units · 8.7 per 100k residents HI Texas: 4,422 units · 14.5 per 100k residents TX Florida: 3,147 units · 13.9 per 100k residents FL
Units reimbursed · per 100k residents
1.4158
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 Delaware 158 /100k
2 Louisiana 123 /100k
3 North Carolina 107 /100k
4 Wisconsin 73.7 /100k
5 Connecticut 53.7 /100k
6 South Dakota 49.6 /100k
7 Mississippi 49.0 /100k
8 Tennessee 47.2 /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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Moxifloxacin ophthalmic solution — the ingredient across all brands.

Top reported reactions

Ocular Hyperaemia2
Rash2
Adverse Event1
Anaphylactic Reaction1
Cholestasis1
Drug Effect Decreased1
Drug-induced Liver Injury1

Reporter sex

0 reports
Male · 20%
Female · 80%

Serious outcomes

Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 62332-0502-03 · Alembic 62332-0506-06 · Alembic →
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.