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MOXIFLOXACIN 5 mg/mL Solution, 3 mL — NDC 68180-0421-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MOXIFLOXACIN 5 mg/mL Solution, 3 mL — NDC 68180-421-01 (Billing 68180-0421-01)

by Lupin Pharmaceuticals, Inc. · 3 mL in 1 BOTTLE

This is a package of 3 mL of MOXIFLOXACIN 5 mg/mL Solution from Lupin Pharmaceuticals, Inc., marketed since Feb 2020 and currently FDA-listed. It is this product's only package size.

NDC 68180-0421-01
🏷️ FDA NDC (as labeled) 68180-421-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 68180-421-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68180 labeler · 421 product · 01 package
Package marketed since
Feb 13, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
3 mL per package
Barcode (UPC-A, from the NDC)
3 6818042101 6
Medicaid fills, this package
89 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) 68180-421-01
Product NDC 68180-421
11-digit billing NDC 68180042101
NCPDP billing unit ML — per mL (volume)
RxCUI 403818
UNII C53598599T
Application # ANDA204079
SPL Set ID d66f080b-da56-4473-8785-920d9700f72d
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 2020-02-13
Route OPHTHALMIC
Dosage form SOLUTION
Substance MOXIFLOXACIN HYDROCHLORIDE

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

GPI-14 86101038102025
GPI class Moxifloxacin HCl (2X Day)
GCN Seq No 067217
GCN 29716
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 DRP-VISC
FDB brand name Moxifloxacin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067217
  • GCN: 29716
  • GPI-14 (Medi-Span): 86101038102025
  • HICL (First Databank): 020690
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 403818
Why two NDCs? The FDA registers this code as 68180-421-01 — 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 → 68180-0421-01. 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 DRP-VISC Ingredient Moxifloxacin Hcl
📖 What it is MedlinePlus · NLM

Moxifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pink eye; infection of the membrane that covers the outside of the eyeballs and the inside of the eyelids). Moxifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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 →
11
Nutrient depletion considerations

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

🧪 Full Moxifloxacin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $45.36 $136.09 / 3 ml
Medicare drug plans payPart D · Q2 2026 $3.70 $11.11 / 3 ml
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
68180-0421-01 You're viewing this Main listing 3 mL in 1 BOTTLE 2020-02-13 — 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/mL 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 —
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/mLthis 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 —
Moxifloxacin 5 mg/mL 50090-8029-00 A-S 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color Green
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LTD
FDA applicationANDA204079 (ANDA)
Labeler code68180
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio404 products on file

More NDCs from Lupin Pharmaceuticals, Inc. labeler code 68180

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 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 153 words ▾

1 INDICATIONS AND USAGE Moxifloxacin Ophthalmic Solution USP is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections.

( 1 ) Moxifloxacin ophthalmic solution USP is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans* Corynebacterium macginleyi* Enterococcus faecalis* Micrococcus luteus* Staphylococcus arlettae* Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus* Staphylococcus warneri* Streptococcus mitis* Streptococcus pneumoniae Streptococcus parasanguinis* Escherichia coli* Haemophilus influenza Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections.

⏱️ Dosage and Administration 33 words ▾

2 DOSAGE AND ADMINISTRATION Instill 1 drop in the affected eye(s) 2 times daily for 7 days. ( 2 ) Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

💊 Dosage Forms and Strengths 18 words ▾

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

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. ( 4 ) None.

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Corneal Endothelial Damage and Toxic Anterior Segment Syndrome : Intracameral injections will cause harm to endothelium. ( 5.1 ) Hypersensitivity Reactions : Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. ( 5.2 ) Prolonged Use : May result in overgrowth of non-susceptible organisms, including fungi.

If superinfection occurs, discontinue use and institute alternative therapy. ( 5.3 ) Avoid Contact Lens Wear : Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.4 )

5.1Corneal Endothelial Damage and Toxic Anterior Segment Syndrome NOT FOR INTRACAMERAL USE OR INJECTION. Moxifloxacin ophthalmic solution will cause damage to the corneal endothelium if introduced directly into the anterior chamber of the eye. Toxic Anterior Segment Syndrome (TASS) has been reported following intraocular administration of moxifloxacin.

TASS is typically characterized by anterior chamber inflammatory reactions, such as fibrin, cell or flare and corneal edema, but other events, such as hypopyon, keratic precipitates or vitreous opacities may also occur.

5.2Hypersensitivity 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.

5.3Growth 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.

5.4Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

🤒 Adverse Reactions 132 words ▾

6 ADVERSE REACTIONS The most common adverse reactions reported in 1% to 2% of patients were eye irritation, pyrexia, and conjunctivitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 data described below reflect exposure to moxifloxacin ophthalmic solution in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1% to 2% of patients.

👥 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 (1420 times the human area under the curve (AUC) at the recommended human ophthalmic dose). The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (152 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 (5569 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 (1261 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 (14688 times the human AUC at the recommended human ophthalmic dose).

The NOAEL for fetal toxicity was 10 mg/kg/day (894 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 1420 times the human AUC at the recommended human ophthalmic dose). The NOAEL for pre- and postnatal development was 100 mg/kg/day (estimated 152 times the human AUC at the recommended human ophthalmic dose).

8.2Lactation Risk Summary There are 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 in infants below 4 months of age have not been established. There is no evidence that th… [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 (1420 times the human area under the curve (AUC) at the recommended human ophthalmic dose). The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (152 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 (5569 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 (1261 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 (14688 times the human AUC at the recommended human ophthalmic dose).

The NOAEL for fetal toxicity was 10 mg/kg/day (894 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 1420 times the human AUC at the recommended human ophthalmic dose). The NOAEL for pre- and postnatal development was 100 mg/kg/day (estimated 152 times the human AUC at the recommended human ophthalmic dose).

🧒 Pediatric Use 55 words ▾

8.4Pediatric Use The safety and effectiveness of moxifloxacin ophthalmic solution in infants below 4 months of age have not been established. There is no evidence that the ophthalmic administration of moxifloxacin 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 [s ee Microbiology ( 12.4 )] .

12.3Pharmacokinetics Moxifloxacin steady-state plasma pharmacokinetics were evaluated in healthy adult male and female subjects who were administered multiple, bilateral, topical ocular doses of moxifloxacin ophthalmic solution two times daily for four days with a final dose on Day 5. The average steady-state AUC 0 to 12 was 8.17 ± 5.31 ng*h/mL. Moxifloxacin C max following twice-daily bilateral ophthalmic administration of moxifloxacin 0.5% for 5 days is approximately 0.02% of that achieved with the oral formulation of moxifloxacin hydrochloride (C max following oral dosing of 400 mg AVELOX ® , 4.5 ± 0.5 mcg/mL).

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 <1x10 -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: Aerococcus viridans* Corynebacterium macginleyi* Enterococcus faecalis* Micrococcus luteus* Staphylococcus arlettae* Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus* Staphylococcus warneri* Streptococcus mitis* Streptococcus pneumoniae Streptococcus parasanguinis* Escherichia coli* Haemophilus influenza Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections.

The following in vitro data are available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of moxifloxacin ophthalmic solution in treating ophthalmic infections due to these organisms have not been established in adequate and well-controlled trials. Moxifloxacin has been shown to be active in vitro against most strains of the microorganisms listed below.

These organisms are considered susceptible when evaluated using systemic breakpoints; however, a correlation between the in vitro systemic breakpoint and ophthalmologic 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 mcg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following ocular pathogens.

Aerobic Gram-Positive Microorganisms Staphylococcus caprae Staphylococcus cohnii Staphylococcus lugdunensis Staphylococcus pasteuri Streptococcus agalactiae Streptococcus milleri group Streptococcus oralis Streptococcus pyogenes Streptococcus salivarius Streptococcus sanguis Aerobic Gram-Negative Microorganisms Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter junii Enterobacter aerogenes Enterobacter cloacae Haemophilus parainfluenzae Klebsiell… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs [s ee Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in a sterile 5 mL natural low density polyethylene bottle fitted with a natural low density polyethylene nozzle and sealed with a tan coloured high density polyethylene cap as follows: 3 mL in a 5 mL bottle (NDC 68180-421-01) Storage: Store at 2°C to 25°C (36°F to 77°F).

📋 Description 125 words ▾

11 DESCRIPTION Moxifloxacin ophthalmic solution USP 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. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8- methoxy-7- [(4aS,7aS)-octahydro- 6H- pyrrolol [3,4-b] pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride.

Each mL of moxifloxacin ophthalmic solution USP, 0.5 % contains 5.45 mg moxifloxacin hydrochloride USP, equivalent to 5 mg moxifloxacin base. Inactives: boric acid, sodium chloride, sorbitol, tyloxapol, xanthan gum, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection. Moxifloxacin ophthalmic solution USP, 0.5% is a greenish-yellow, isotonic solution with an osmolality of 300 to 370 mOsm/kg and a pH of approximately 7.4.

Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. USP pH and Osmolality tests are pending. figure 1

💬 Information for Patients 143 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. Hypersensitivity Reactions Systemically administered quinolones, including moxifloxacin, have been associated with hypersensitivity reactions, even following a single dose.

Advise patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction [see Warnings and Precautions (5.2)]. AVELOX ® is the registered trademark of the Bayer AG and is not the trademark of Lupin Limited. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.

Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. Manufactured by: Lupin Limited Pithampur (M.

P.) - 454 775 India. Revised: November 2024 ID: 277377 Image

🍼 Nursing Mothers 125 words ▾

8.2Lactation Risk Summary There are 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.

🧬 Pharmacokinetics 94 words ▾

12.3Pharmacokinetics Moxifloxacin steady-state plasma pharmacokinetics were evaluated in healthy adult male and female subjects who were administered multiple, bilateral, topical ocular doses of moxifloxacin ophthalmic solution two times daily for four days with a final dose on Day 5. The average steady-state AUC 0 to 12 was 8.17 ± 5.31 ng*h/mL. Moxifloxacin C max following twice-daily bilateral ophthalmic administration of moxifloxacin 0.5% for 5 days is approximately 0.02% of that achieved with the oral formulation of moxifloxacin hydrochloride (C max following oral dosing of 400 mg AVELOX ® , 4.5 ± 0.5 mcg/mL).

🔬 Clinical Studies 100 words ▾

14 CLINICAL STUDIES In one randomized, double-masked, multicenter, vehicle-controlled clinical trial in which patients with bacterial conjunctivitis were dosed with moxifloxacin ophthalmic solution 2 times a day, moxifloxacin ophthalmic solution was superior to its vehicle for both clinical and microbiological outcomes. Clinical cure achieved on Day 4 was 63% (265/424) in moxifloxacin ophthalmic solution treated patients, versus 51% (214/423) in vehicle-treated patients. Microbiologic success (eradication of baseline pathogens) was achieved on Day 4 in 75% (316/424) of moxifloxacin ophthalmic solution-treated patients versus 56% (237/423) of vehicle treated patients.

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 (4741 times the recommended 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 4741 times the highest recommended daily human ophthalmic dose.

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.

📄 Recent Major Changes 8 words ▾

RECENT MAJOR CHANGES Warnings and Precautions (5.1) 8/2021

📄 Package Label / Principal Display Panel 13 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Moxifloxacin Ophthalmic Solution USP, 0.5% NDC 68180-421-01 container carton

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
89
Units reimbursed last 4 qtrs
267
Gross reimbursed last 4 qtrs
$12.1K
Avg / prescription
$136.09
Avg / unit
$45.3630
Latest quarter Q1 2026
24Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 89 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 267 units · 0.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.90.9
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 Texas 0.9 /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.

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

Medicare Part D (outpatient prescription) spending for Moxifloxacin — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Moxifloxacin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.91M
Claims incl. refills
268.9K
Beneficiaries
202.9K
Spend / beneficiary
$24.17
Spend / claim
$18.24
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 — the ingredient across all brands.

Top reported reactions

Dyspnoea2,204
Asthma2,071
Drug Hypersensitivity2,056
Pneumonia1,997
Vomiting1,856
Pain1,738
Wheezing1,664

Reporter sex

20,168 reports

Serious outcomes

Hospitalization6,896
Death2,667
Life-threatening1,818
Disabling1,092
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 2,483 903
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lupin Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68180-0412-02 · Lupin 68180-0422-01 · Lupin →
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.