HomeNDC LookupIngredientsMoxifloxacin › 72189-0334-05
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MOXIFLOXACIN 5 mg/mL Solution/ Drops, 3 mL

by Direct Rx · 3 mL in 1 BOTTLE (72189-334-05)
NDC 72189-0334-05
🏷️ FDA NDC (as labeled) 72189-334-05 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 72189-334-05
Product NDC 72189-334
11-digit billing NDC 72189033405
RxCUI 403818
UNII C53598599T
Application # ANDA202916
SPL Set ID d9b6a460-6377-76d0-e053-2995a90a3d05
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 2022-03-08
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance MOXIFLOXACIN HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 72189-334-05 — 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 → 72189-0334-05. 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.

🏭 Manufacturer & labeler

LabelerDirect Rx
Application holderEPIC PHARMA LLC
FDA applicationANDA202916 (ANDA)
Labeler code72189
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Yes — you can take moxifloxacin with or without food, and even a big, fatty meal or a cup of yogurt won't affect how well it works. The one thing to watch is timing with antacids,...
  • Can I eat or drink normally while taking moxifloxacin tablets?
  • The most common ones are nausea, diarrhea, headache, and dizziness — these are annoying but usually manageable. What you really need to stop the medication for and call your doctor...
  • What side effects should I actually expect, and which ones should make me stop taking it?
📖 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.

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.

🧪 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.

💲 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 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 $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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Moxifloxacin Ophthalmic Solution 5 mg/mL 00781-7135-93 Sandoz 1 bottle $1.539 AT1 Availability likely
Moxifloxacin Hydrochloride 5 mg/mL 00832-1410-03 Upsher-Smith 1 bottle $1.539 AT1 Availability likely
Moxifloxacin 5 mg/mL 16714-0643-01 NorthStar 1 bottle $1.539 AT1 Availability likely
Moxifloxacin 5 mg/mL 60505-0582-04 Apotex 1 bottle $1.539 AT1 Availability likely
Moxifloxacin ophthalmic solution 5 mg/mL 62332-0505-03 Alembic 1 bottle $1.539 AT1 Availability likely
Moxifloxacin 5 mg/mL 65862-0840-03 Aurobindo 1 bottle $1.539 AT1 Availability likely
Moxifloxacin 5 mg/mL 68180-0422-01 Lupin 1 bottle $1.539 AT1 Availability likely
Moxifloxacin Hydrochloride 5 mg/mL 70069-0081-01 Somerset 1 bottle $1.539 AT1 Availability likely
Moxifloxacin ophthalmic solution 5 mg/mL 70756-0638-25 Lifestar 1 bottle $1.539 AT1 Availability likely
Moxifloxacin Ophthalmic Solution 5 mg/mL 72266-0158-01 Fosun 1 bottle $1.539 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/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/mLthis 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0334-05 You're viewing this 3 mL in 1 BOTTLE (72189-334-05) 2022-03-08 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 72189-334-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0334-05, written without dashes as 72189033405. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0334-05, the first segment (72189) is the labeler code FDA assigned to Direct Rx; the middle segment (0334) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Direct Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct Rx 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 57 words

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 infection

⏱️ Dosage and Administration 20 words

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

💊 Dosage Forms and Strengths 5 words

Ophthalmic solution containing moxifloxacin 0.5%.

Contraindications 26 words

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 159 words

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 102 words

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% to 6% of patients.

Nonocular adverse events reported at a rate of 1% to 4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

🔄 Drug Interactions 43 words

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

8.1Pregnancy 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 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 (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 (1,086 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 (2,864 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 have been established in all ages. Use of moxifloxacin ophthalmic solution is supported by evidence from adequate and well c…

📦 How Supplied / Storage and Handling 65 words

Moxifloxacin Ophthalmic Solution, USP 0.5% is supplied as a sterile ophthalmic solution in a dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. NDC 17478-519-19 3 mL in 5 mL bottle Storage: Store at 2° to 25°C (36° to 77°F).

📋 Description 134 words

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 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.

The molecular formula for moxifloxacin hydrochloride is C12H24FN3O4•HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: [Chemical Structure] 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 contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. 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.

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