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AzaSITE Azithromycin Monohydrate 10 mg/mL Solution/ Drops, 1 bottle — NDC 17478-0307-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AzaSITE Azithromycin Monohydrate 10 mg/mL Solution/ Drops, 1 bottle — NDC 17478-307-03 (Billing 17478-0307-03)

by Akorn · 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER

This is a package of 1 bottle of AzaSITE Azithromycin Monohydrate 10 mg/mL Solution/ Drops from Akorn, no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $85.78 per mL (NADAC). It is this product's only package size.

NDC 17478-0307-03
🏷️ FDA NDC (as labeled) 17478-307-03 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 17, 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 17478-307-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17478 labeler · 307 product · 03 package
Barcode (UPC-A, from the NDC)
3 1747830703 7
FDA record last changed
Jul 17, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17478-307-03
Product NDC 17478-307
11-digit billing NDC 17478030703
NCPDP billing unit ML — per mL (volume)
Application # NDA050810
SPL Set ID 14ae4c07-b042-452a-b069-2b41bc646e04
Chemical class Macrolide Antimicrobial [EPC], Macrolides
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance AZITHROMYCIN MONOHYDRATE

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

GPI-14 86101004002020
GCN Seq No 062828
GCN 98599
HICL code 006334
Ingredient (HICL) Azithromycin
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 52:04.04.00
AHFS class Antibacterials (52:04)
FDB label name AZASITE 1% EYE DROPS
FDB brand name Azasite
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 062828
  • GCN: 98599
  • GPI-14 (Medi-Span): 86101004002020
  • HICL (First Databank): 006334
  • AHFS class code: 52:04.04.00
Why two NDCs? The FDA registers this code as 17478-307-03 — 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 → 17478-0307-03. 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.

Clinical

Label name AZASITE 1% EYE DROPS Ingredient Azithromycin
📖 What it is MedlinePlus · NLM

Azithromycin ophthalmic is used to treat certain bacterial infections of the eye. Azithromycin ophthalmic is in a class of medications called macrolide antibiotics. It works by slowing the growth of bacteria that cause infections.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats certain bacterial infections, such as sinus infections, pneumonia, bronchitis flare-ups, strep-type throat infections, ear infections in children, skin infections and som...
  • The tablets can be taken with or without food. If it upsets your stomach, taking it with a meal may help. Follow the directions on your label.
  • The most common are diarrhea, nausea, stomach pain and vomiting, and they are usually mild. Call your doctor if you have a rash, swelling, yellow skin or eyes, a racing or irregula...
  • Tell me about everything you take. Azithromycin may increase the effect of warfarin, so your clotting tests should be monitored. Medicines that affect heart rhythm, such as amiodar...
📖 Read our full Azithromycin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

Azithromycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Azithromycin 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 $85.783 $214.46 / 2.5 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 $85.783 $85.783
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
17478-0307-03 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER 2014-05-14 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AzaSITE 10 mg/mLthis 17478-0307-03 Akorn 1 bottle $85.783 — Discontinued —
Azasite 10 mg/mL 82584-0307-02 Thea 1 bottle — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🧪 Avoiding an ingredient? See Azithromycin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.03 mg / 1 mL UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII W25LM17A4W
    Polycarbophil is a synthetic polymer that absorbs water and swells. It's used as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAkorn
Application holderTHEA PHARMA INC
FDA applicationNDA050810 (NDA)
Labeler code17478
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 84 words ▾

1 INDICATIONS AND USAGE AzaSite ® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G* Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae * Efficacy for this organism was studied in fewer than 10 infections. AzaSite is a macrolide antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.

( 1 )

⏱️ Dosage and Administration 88 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days. Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days. ( 2 )

💊 Dosage Forms and Strengths 25 words ▾

3 DOSAGE FORMS AND STRENGTHS 2.5 mL of a 1% sterile topical ophthalmic solution. 2.5 mL of 1% sterile topical ophthalmic solution. ( 3 )

⛔ Contraindications 13 words ▾

4 CONTRAINDICATIONS Hypersensitivity to any component of this product. Hypersensitivity ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS For topical ophthalmic use only. ( 5.1 ) Anaphylaxis and hypersensitivity have been reported with systemic use of azithromycin. ( 5.2 ) Growth of resistant organisms may occur with prolonged use. ( 5.3 ) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.4 )

5.1Topical Ophthalmic Use Only NOT FOR INJECTION. AzaSite is indicated for topical ophthalmic use only, and should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.

5.2Anaphylaxis and Hypersensitivity with Systemic Use of Azithromycin In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. The potential for anaphylaxis or other hypersensitivity reactions should be considered based on known hypersensitivity to azithromycin when administered systemically.

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 super-infection 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 Lenses Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

🤒 Adverse Reactions 192 words ▾

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to AzaSite in 698 patients. The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis.

The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation. This reaction occurred in approximately 1-2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).

Most common adverse reaction reported in patients was eye irritation (1-2% of patients). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Akorn, Inc. at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations 203 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/day. The highest dose was associated with moderate maternal toxicity.

These doses are estimated to be approximately 5,000 times the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.

8.3Nursing Mothers It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials [see Clinical Studies ( 14 )] .

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

🤰 Pregnancy 95 words ▾

8.1Pregnancy Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/day. The highest dose was associated with moderate maternal toxicity.

These doses are estimated to be approximately 5,000 times the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 51 words ▾

8.4Pediatric Use The safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials [see Clinical Studies ( 14 )] .

🧓 Geriatric Use 18 words ▾

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

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Azithromycin is a macrolide antibiotic [see Clinical Pharmacology ( 12.4 )] .

12.3Pharmacokinetics The plasma concentration of azithromycin following ocular administration of AzaSite (azithromycin ophthalmic solution) in humans is unknown. Based on the proposed dose of one drop to each eye (total dose of 100 mcL or 1 mg) and exposure information from systemic administration, the systemic concentration of azithromycin following ocular administration is estimated to be below quantifiable limits (≤10 ng/mL) at steady-state in humans, assuming 100% systemic availability.

12.4Microbiology Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in conjunctival infections [see Indications and Usage ( 1 )] . CDC coryneform group G* Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae * 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 AzaSite in treating ophthalmological infections due to these microorganisms have not been established. The following microorganisms are considered susceptible when evaluated using systemic break points.

However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. This list of microorganisms is provided as an aid only in assessing the potential treatment of conjunctival infections. Azithromycin exhibits in vitro minimal inhibitory concentrations (MICs) of equal or less (systemic susceptible breakpoint) against most (≥90%) of isolates of the following ocular pathogens: Chlamydia pneumoniae Chlamydia trachomatis Legionella pneumophila Moraxella catarrhalis Mycoplasma hominis Mycoplasma pneumoniae Neisseria gonorrhoeae Peptostreptococcus species Streptococci (Groups C, F, G) Streptococcus pyogenes Streptococcus agalactiae Ureaplasma urealyticum Viridans group streptococci

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Azithromycin is a macrolide antibiotic [see Clinical Pharmacology ( 12.4 )] .

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AzaSite is a sterile aqueous topical ophthalmic formulation of 1% azithromycin. NDC 17478-307-03: 2.5 mL in 5 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.

NDC 17478-307-04: 2.5 mL in 4 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided. Storage and Handling: Store unopened bottle under refrigeration at 2° to 8°C (36° to 46°F).

Once the bottle is opened, store at 2° to 25°C (36° to 77°F) for up to 14 days. Discard after the 14 days.

📦 Storage and Handling 38 words ▾

Storage and Handling: Store unopened bottle under refrigeration at 2° to 8°C (36° to 46°F). Once the bottle is opened, store at 2° to 25°C (36° to 77°F) for up to 14 days. Discard after the 14 days.

📋 Description 109 words ▾

11 DESCRIPTION AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite ® (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of approximately 290 mOsm/kg. Preservative: 0.003% benzalkonium chloride.

Inactives: mannitol, citric acid, sodium citrate, poloxamer 407, polycarbophil, edetate disodium (EDTA), sodium chloride, water for injection, and sodium hydroxide to adjust pH to 6.3. Azithromycin is a macrolide antibiotic with a 15-membered ring. Its chemical name is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]1-oxa-6-aza-cyclopentadecan-15-one, and the structural formula is: Azithromycin has a molecular weight of 749, and its empirical formula is C 38 H 72 N 2 O 12 .

Structural Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling ( Patient Information ). Patients should be advised to avoid contaminating the applicator tip by allowing it to touch the eye, fingers or other sources. Patients should be directed to discontinue use and contact a physician if any signs of an allergic reaction occur.

Patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AzaSite (azithromycin ophthalmic solution) or other antibacterial drugs in the future. Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Patients should be advised to thoroughly wash hands prior to using AzaSite. Patients should be advised to invert the closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position.

Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s). AKORN Distributed by: Akorn, Inc. Lake Forest, IL 60045 U.S.

Patent Nos.: 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pending AzaSite is a registered trademark of InSite Vision Inc. OPZT00N Rev. 06/17

🍼 Nursing Mothers 34 words ▾

8.3Nursing Mothers It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

🧬 Pharmacokinetics 69 words ▾

12.3Pharmacokinetics The plasma concentration of azithromycin following ocular administration of AzaSite (azithromycin ophthalmic solution) in humans is unknown. Based on the proposed dose of one drop to each eye (total dose of 100 mcL or 1 mg) and exposure information from systemic administration, the systemic concentration of azithromycin following ocular administration is estimated to be below quantifiable limits (≤10 ng/mL) at steady-state in humans, assuming 100% systemic availability.

🔬 Clinical Studies 138 words ▾

14 CLINICAL STUDIES In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%.

The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p<0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

🧪 Nonclinical Toxicology 138 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. No evidence of impaired fertility due to azithromycin was found in mice or rats that received oral doses of up to 200 mg/kg/day.

13.2Animal Toxicology and/or Pharmacology Phospholipidosis (intracellular phospholipid accumulation) has been observed in some tissues of mice, rats, and dogs given multiple systemic doses of azithromycin. Cytoplasmic microvacuolation, which is likely a manifestation of phospholipidosis, has been observed in the corneas of rabbits given multiple ocular doses of AzaSite. This effect was reversible upon cessation of AzaSite treatment.

The significance of this toxicological finding for animals and for humans is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 64 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. No evidence of impaired fertility due to azithromycin was found in mice or rats that received oral doses of up to 200 mg/kg/day.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION AzaSite ® (A-zuh-site) (azithromycin ophthalmic solution) 1% Read this Patient Information before you start using AzaSite ® and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is AzaSite? AzaSite is a prescription sterile eye drop solution. AzaSite is used to treat bacterial conjunctivitis which is an infection of the eye caused by certain bacteria.

It is not known if AzaSite is safe and effective in children less than 1 year of age. Information about bacterial conjunctivitis. Bacterial conjunctivitis is a bacterial infection of the mucous membranes which line the inside of the eyelids.

Symptoms may include redness of the eye and discharge. The infection can be spread to other people and to both eyes. Who should not use AzaSite?

Do not use AzaSite if you are allergic to azithromycin or any of the ingredients in AzaSite. See the end of this Patient Information leaflet for a complete list of the ingredients in AzaSite. What should I tell my doctor before using AzaSite?

Before you use AzaSite, tell your doctor if you: wear contact lenses. Do not wear contact lenses if you have signs or symptoms of bacterial conjunctivitis. are pregnant or plan to become pregnant. It is not known if AzaSite will harm your unborn baby.

Talk to your doctor if you are pregnant or plan to become pregnant. are breast-feeding or plan to breast-feed. It is not known if AzaSite passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using AzaSite.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctors and pharmacist when you get a new medicine.

How should I use AzaSite? Read the Instructions for Use at the end of this Patient Information leaflet for the right way to use AzaSite. Use AzaSite exactly as your doctor tells you to use it.

For the first 2 days place 1 drop of AzaSite in your eye (or eyes) each morning and 1 drop in your eye (or eyes) each evening. Wait 8 to 12 hours after placing your morning drops before you place evening drops in your eye (or eyes). For the next 5 days place 1 drop of AzaSite in your eye (or eyes) 1 time each day.

Make sure you continue to use AzaSite as directed by your doctor even if you feel better after you start using it. Skipping drops can increase the chances that: your medicine will not work well Bacteria can develop resistance, which means in the future your bacterial conjunctivitis may not improve from AzaSite or other drugs that treat infections from bacteria. What should I be aware of while using AzaSite?

Do not wear contact lenses if you have signs or symptoms of bacterial conjunctivitis and until you have finished your prescribed course of treatment. The symptoms of bacterial conjunctivitis may include: discharge coming from the eye eye redness eye irritation Only your doctor can tell you if you have bacterial conjunctivitis. Severe allergic reactions have been reported rarely when azithromycin has been taken by mouth.

Serious rash or serious allergic reactions may occur. Azithromycin, the active ingredient in AzaSite, may cause a serious rash or a serious allergic reaction. Both of these reactions may need to be treated in a hospital and may be life-threatening.

Stop taking AzaSite and call your doctor right away or get emergency help if you have any of these symptoms: skin rash, hives, sores in your mouth, or your skin blisters and peels swelling of your face, eyes, lips, tongue, or throat trouble swallowing or breathing Increased risk of other infections caused by bacteria or fungi. Using AzaSite for a long time may cause other bacteria or fungi to grow. If this happens you may get a new infection.

Tell your doctor right away if your symptoms do not get better. What are the… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~2 min read ▾

Instructions for Use AzaSite ® (A-zuh-site) (azithromycin ophthalmic solution) 1% Read this Instructions for Use for AzaSite before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

Important: AzaSite is for use as an eye drop only. The checklist below tells you when to use your medicine for each eye that has bacterial conjunctivitis: This is a total of 9 drops of AzaSite for each infected eye. Avoid letting the applicator tip touch your eye, your fingers, or other objects.

If a drop misses your eye, try again. Follow the steps below to use AzaSite correctly. Before using a new bottle of AzaSite: Turn the white cap clockwise until it comes off.

Throw away the white cap. See Figure A Hold the bottle straight, turn the tan cap counterclockwise until it comes off. Put the tan cap back on the bottle and close tightly.

(This lets out the air.) See Figure B Wash your hands each time you use AzaSite. To use AzaSite: Step 1. Turn the closed bottle upside down.

See Figure C Step 2. Shake your hand firmly. This helps move the medicine into the tip of the bottle.

See Figure D Step 3. Hold the bottle upside down and take off the tan cap. See Figure E Step 4.

Tilt your head back. Hold the bottle over your eye and gently squeeze the bottle to let 1 drop into each eye that has bacterial conjunctivitis. Put the tan cap back on the bottle and close tightly.

See Figure F If a drop does not come out of the bottle, repeat steps one to four. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

AKORN Distributed by: Akorn, Inc. Lake Forest, IL 60045 U.S. Patent Nos.: 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pending AzaSite is a registered trademark of InSite Vision Inc.

OPZTA0N Rev. 06/17 Checklist Figure A Figure B Figure C Figure D Figure E Figure F

📄 Package Label / Principal Display Panel 58 words ▾

Principal Display Panel Text for Container Label: NDC 17478-307-03 AzaSITE ® (azithromycin ophthalmic solution) 1% Rx Only Sterile 2.5 mL Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label: NDC 17478-307-03 AzaSITE ® (azithromycin ophthalmic solution) 1% Sterile 2.5 mL Rx Only FOR OPHTHALMIC USE ONLY Principal Display Panel Text for Carton Label

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

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

Medicare Part D (outpatient prescription) spending for Azasite — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Azasite. 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
$173.5K
Claims incl. refills
584
Beneficiaries
488
Spend / beneficiary
$355.62
Spend / claim
$297.16
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 AZASITE (this brand).

Top reported reactions

Product Quality Issue276
Inappropriate Schedule Of Drug Administration211
Eye Irritation195
Product Packaging Quantity Issue146
Eye Pain105
Eye Pruritus105
Dyspnoea98

Reporter sex

1,462 reports

Serious outcomes

Hospitalization168
Death24
Life-threatening13
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 73 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Akorn 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.
← 17445-6888-00 · Sigma-Aldrich 17504-0007-02 · Lonza →
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.